U.S. patent application number 12/894912 was filed with the patent office on 2011-04-07 for medical device, kit and method for constricting tissue or a bodily orifice, for example, a mitral valve.
Invention is credited to Jonathan Dahlgren, Daniel Gelbart, Douglas Goertzen, Derrick To, Kelly Watkinson.
Application Number | 20110082538 12/894912 |
Document ID | / |
Family ID | 43823804 |
Filed Date | 2011-04-07 |
United States Patent
Application |
20110082538 |
Kind Code |
A1 |
Dahlgren; Jonathan ; et
al. |
April 7, 2011 |
MEDICAL DEVICE, KIT AND METHOD FOR CONSTRICTING TISSUE OR A BODILY
ORIFICE, FOR EXAMPLE, A MITRAL VALVE
Abstract
A device, kit and method may include or employ an implantable
device (e.g., annuloplasty implant) and a tool operable to implant
such. The implantable device is positionable in a cavity of a
bodily organ (e.g., a heart) and operable to constrict a bodily
orifice (e.g., a mitral valve). The tissue anchors may be guided
into precise position by an intravascularly or percutaneously
deployed anchor guide frame of the tool and embedded in an annulus
of the orifice. Constriction of the orifice may be accomplished via
a variety of structures, for example by cinching a flexible cable
or via a anchored annuloplasty ring, the cable or ring attached to
the tissue anchors. The annuloplasty ring may be delivered in an
unanchored, generally elongated configuration, and implanted in an
anchored generally arch, arcuate or annular configuration. Such may
approximate the septal and lateral (clinically referred to as
anterior and posterior) annulus of the mitral valve, to move the
posterior leaflet anteriorly and the anterior leaflet posteriorly,
thereby improving leaflet coaptation to eliminate mitral
regurgitation.
Inventors: |
Dahlgren; Jonathan; (Surrey,
CA) ; Goertzen; Douglas; (New Westminster, CA)
; Gelbart; Daniel; (Vancouver, CA) ; Watkinson;
Kelly; (Burnaby, CA) ; To; Derrick;
(Vancouver, CA) |
Family ID: |
43823804 |
Appl. No.: |
12/894912 |
Filed: |
September 30, 2010 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
61278232 |
Oct 1, 2009 |
|
|
|
Current U.S.
Class: |
623/2.11 ;
623/2.36 |
Current CPC
Class: |
A61B 2017/0437 20130101;
A61B 17/00234 20130101; A61F 2210/0014 20130101; A61B 2017/0409
20130101; A61B 17/0482 20130101; A61B 2017/00411 20130101; A61B
2017/0464 20130101; A61F 2/2466 20130101; A61B 2017/22038 20130101;
A61B 2017/00783 20130101; A61B 17/0487 20130101; A61F 2230/0091
20130101; A61B 17/0469 20130101; A61B 2017/00243 20130101; A61B
2017/0496 20130101; A61B 2017/045 20130101; A61B 2017/00867
20130101; A61F 2220/0016 20130101; A61B 2017/003 20130101; A61F
2/2445 20130101; A61B 2017/0441 20130101 |
Class at
Publication: |
623/2.11 ;
623/2.36 |
International
Class: |
A61F 2/24 20060101
A61F002/24 |
Claims
1. An implant kit comprising: a plurality of tissue anchors
comprising at least a first tissue anchor, a second tissue anchor
and a third tissue anchor; a percutaneous delivery system operable
to at least partially embed each of the tissue anchors into a
respective location about a periphery of an orifice in a tissue
within a body during an implant procedure in which a location of
the embedded third tissue anchor is laterally offset by a first
distance from a first axis, the first axis extending between a
location of the embedded first tissue anchor and a location of the
embedded second tissue anchor; an implant member reconfigurable
between a delivery configuration in which the implant member is
manipulable to a size and dimension to be deliverable
percutaneously to the tissue within the body, and an implantable
configuration in which the implantable member forms a structure
sufficiently rigid to affect a shape of the orifice in the tissue,
the implant member further comprising a plurality of tissue anchor
receivers, each of the tissue anchor receivers positioned to
physically couple with a respective one of the embedded tissue
anchors, the plurality of tissue anchor receivers comprising at
least a first tissue anchor receiver corresponding to the first
tissue anchor, a second tissue anchor receiver corresponding to the
second tissue anchor, and a third tissue anchor receiver
corresponding to the third tissue anchor, wherein a location of the
third tissue anchor receiver on the implant member in the
implantable configuration is laterally offset by a second distance
from a second axis, the second axis extending between a location of
the first tissue anchor receiver on the implant member and a
location of the second tissue anchor receiver on the implant
member, wherein the second distance is smaller than the first
distance; and a plurality of implant guide lines that in use during
the implant procedure provide a physical path for the implant
member to the embedded tissue anchors.
2. The implant kit of claim 1 wherein the implant member comprises
a plurality of segments physically coupled to one another, the
segments being articuable with respect to one another as the
implant member is moved between the deliverable configuration and
the implantable configuration.
3. The implant kit of claim 2 wherein the implant member comprises
a number of hinges that physically couple each of the segments to
at least one other of the segments.
4. The implant kit of the claim 3 wherein the implant member
comprises a number of stops configured to increase a torsional
stiffness of each of the hinges when each of the segments pivots by
a defined amount with respect to another of the segments.
5. The implant kit of claim 2 wherein the implant member comprises
a number of flexure joints that physically couple each of the
segments to at least one other of the segments.
6. The implant kit of claim 5 wherein the implant member comprises
a number of stops configured to increase a bending stiffness of
each of the flexure joints when each of the segments flexes by a
defined amount with respect to another of the segments.
7. The implant kit of claim 2 wherein the implant member comprises
a number of stops configured to restrain articulation between the
coupled segments.
8. The implant kit of claim 1 wherein each of the tissue anchors
comprises at least one barb.
9. The implant kit of claim 1 wherein each of the tissue anchors is
a helical tissue anchor.
10. The implant kit of claim 1 wherein each of the tissue anchors
is a grapple tissue anchor, each grapple tissue anchor comprising
at least two prongs pivotally coupled to each other, and each of
the two prongs having a tip shaped to pierce the tissue.
11. The implant kit of claim 1 wherein the implant member has at
least three guide line receivers that each ride on respective ones
of the guide lines, wherein a circumference defined by a circle
passing through at least three locations of the at least three
guide line receivers on the implant member in the implantable
configuration is smaller than a circumference defined by a circle
passing through the respective locations of the embedded first,
second and third tissue anchors prior to a physical coupling
between each of the embedded first, second and third tissue anchors
and respective ones of the first, second and third tissue anchor
receivers.
12. An implant kit, comprising: an implant member configured to
affect a shape of an orifice in tissue within a body during an
implant procedure, a portion of the implant member having a
variable bending stiffness in at least one dimensional plane, the
implant member comprising a first end, a second end and a plurality
of guide line receivers positioned between the first end and the
second end along the implant member, the implant member configured
to be bendable between a first configuration in which implant
member has an elongated shape and a second configuration in which
the implant has an arcuate shape, the first end being spaced apart
from the second end by a greater distance when the implant member
is in the first configuration than when the implant member is in
the second configuration, and the portion of the implant member
having a reduced bending stiffness in the at least one dimensional
plane when the implant member is in first configuration and an
increased bending stiffness in the at least one dimensional plane
when the implant member is in the second configuration; a plurality
of tissue anchors configured to be at least partially embedded into
tissue at respective locations about the orifice in the tissue
within the body; and a plurality of guide lines, each of the guide
lines sized to be received by a respective one of the guide line
receivers and a respective one of the tissue anchors, each of at
least one of the guide lines being configured to receive a tensile
force sufficient to move a portion of the tissue into which a
respective tissue anchor is embedded towards the implant member in
the second configuration.
13. The implant kit of claim 12, the implant member comprising a
plurality of tissue anchor receivers positioned along the implant
member between the first end and the second end, each of the tissue
anchor receivers configured to physically receive a respective one
of the tissue anchors, and wherein each of the at least one of the
guide lines is configured to receive a tensile force sufficient to
move the portion of the tissue to a position where the respective
tissue anchor embedded into the portion of the tissue is physically
received by a respective tissue anchor receiver when the implant
member in the second configuration.
14. The implant kit of claim 13 wherein the implant member
comprises a plurality of segments physically coupled to one
another, the segments being articuable with respect to one another
to provide the reduced bending stiffness in the at least one
dimensional plane when the implant member is in the first
configuration.
15. The implant kit of claim 14 wherein the implant member
comprises a number of hinges that physically couple each of the
segments to at least one other of the segments.
16. The implant kit of the claim 15 wherein the implant member
comprises a number of stops configured to increase a torsional
stiffness of each of the hinges when each of the segments pivots by
a defined amount with respect to another of the segments to provide
the increased bending stiffness in the at least one dimensional
plane when the implant member is in the second configuration.
17. The implant kit of claim 14 wherein the implant member
comprises a number of flexure joints that physically couple each of
the segments to at least one other of the segments.
18. The implant kit of claim 17 wherein the implant member
comprises a number of stops configured to provide the increased
bending stiffness in the at least one dimensional plane when the
implant member is in the second configuration.
19. The implant kit of claim 14 wherein the implant member
comprises a number of stops configured to restrain articulation
between the coupled segments to provide the increased bending
stiffness in the at least one dimensional plane when the implant
member is in the second configuration.
20. The implant kit of claim 19 wherein the embedded tissue anchors
apply tension to implant member in the second configuration when
each of the tissue anchor receivers is coupled with a respective
one of the embedded tissue anchors.
21. The implant kit of claim 20 wherein the applied tension is
sufficient to restrain disengagement of each of the coupled
segments with an associated one of the stops.
22. The implant kit of claim 20 wherein the applied tension is
sufficient to flex at least one of segments while each of the at
least one of the segments is engaged with an associated one of the
stops.
23. The implant kit of claim 13 wherein each of the tissue anchors
comprises at least one piercing element configured for piercing the
tissue.
24. The implant kit of claim 13 wherein each of the tissue anchors
is a helical tissue anchor.
25. The implant kit of claim 13 wherein each of the tissue anchors
is a grapple tissue anchor, each grapple tissue anchor comprising
at least two prongs pivotally coupled to each other, and each of
the two prongs having a tip shaped to pierce the tissue.
26. The implant kit of claim 13 wherein the plurality of guide line
receivers comprise at least three guide line receivers, a
circumference defined by a circle passing through at least three
locations of the at least three guide line receivers on the implant
member in the second configuration being smaller than a
circumference defined by a circle passing through at least three
locations of their respective embedded tissue anchors about the
orifice in the tissue prior to a physical coupling between any of
the tissue anchor receivers and their respective embedded tissue
anchors.
27. The implant kit of claim 13 wherein the implant member in the
first configuration is manipulable to a size and dimension to be
deliverable via a catheter.
28. The implant kit of claim 13, wherein the portion of the implant
member has a substantially equal bending stiffness in each of a
plurality of directions in the at least one dimensional plane when
the implant member is in the first configuration and the portion of
the implant member has a substantially unequally bending stiffness
in each of the plurality of directions in the at least one
dimensional plane when the implant member is in the second
configuration.
29. An implant kit, comprising: a plurality of tissue anchors
configured to be at least partially embedded into tissue at
respective locations about an orifice in the tissue during an
implant procedure; an implant member having a plurality of segments
physically coupled to one another, in a delivery configuration the
segments being articulable with respect to one another by a
respective articulation joint such that the implant member is
manipulable to a size and dimension to be deliverable via a
catheter and in an deployed configuration the segments form a
structure sufficiently rigid to affect a shape of the orifice in
the tissue when the implant member is positioned to physically
couple with the embedded tissue anchors; and a plurality of implant
guide lines that in use during the implant procedure provide a
physical path for the implant member to respective ones of the
embedded tissue anchors, the implant member moveable along the
physical path to a position where the implant member is secured to
the tissue under tension in the deployed configuration.
30. The implant kit of claim 29 wherein the tissue anchors and
respective ones of the guide lines are integral structures
comprised of at least one of a metal wire.
31. The implant kit of claim 29 wherein the tissue anchors and
respective ones of the guide lines are unitary structures, each of
the tissue anchors comprising at least one piercing element at a
distal end of a respective one of the guide lines, wherein the at
least one piercing element is configured to pierce the tissue.
32. The implant kit of claim 29 wherein the structure formed by the
segments of the implant member has a C-shape profile.
33. The implant kit of claim 29, further comprising: an implant
cross connector attachable across an open portion of the implant
member such that when attached, the implant cross connector and the
structure formed by the segments of the implant member have a
D-shape profile.
34. The implant kit of claim 29 wherein the implant member has a
number of guide line receivers that ride on respective ones of the
guide lines.
35. The implant kit of claim 29 wherein the implant member has at
least three guide line receivers, at least a first guide line
receiver proximate a first end of the implant member, a second
guide line receiver proximate a second end of the implant member,
and a third guide line receiver positioned along the structure
formed by the segments between the first and the second guide line
receivers.
36. The implant kit of claim 29 wherein the respective articulation
joint of the implant member comprises a number of hinges that
physically couple each of the segments of the implant member to at
least one other of the segments of the implant member.
37. The implant kit of claim 36 wherein the implant member
comprises a number of stops configured to limit a travel of each of
the segments of the implant member with respect to another of the
segments of the implant member.
38. The implant kit of claim 36 wherein the implant member
comprises a number of stops configured to increase a torsional
stiffness of each of the hinges when each of the segments of the
implant member pivots by a defined amount with respect to another
of the segments of the implant member.
39. The implant kit of claim 29 wherein the respective articulation
joint of the implant member comprises a number of flexure joints
that physically couple each of the segments of the implant member
to at least one other of the segments of the implant member.
40. The implant kit of claim 39 wherein the implant member
comprises a number of stops configured to limit a travel of each of
the segments of the implant member with respect to another of the
segments of the implant member.
41. The implant kit of claim 39 wherein the implant member
comprises a number of stops configured to increase a bending
stiffness of each of the flexure joints when each of the segments
of the implant member flexes by a defined amount with respect to
another of the segments of the implant member.
42. The implant kit of claim 29, further comprising: an anchor
guide frame having at least three anchor guide arms, wherein each
of the tissue anchors is configured to be physically releasably
guided by a respective one of the anchor guide arms of the anchor
guide frame to a respective location on an annulus about the
orifice in the tissue and embedded in the annulus at least
proximate the respective locations.
43. The implant kit of claim 42 wherein the anchor guide arms each
comprise an outer tube having at least a first outer tube lumen,
and an inner tube having an inner tube lumen, the inner tube
received in the first outer tube lumen of the outer tube for
translational movement between a retracted position in which a
distal end of the inner tube does not extend beyond a distal end of
the first outer tube lumen and an extended position in which the
distal end of the inner tube extends beyond the distal end of the
first outer tube lumen, the inner tube lumen of the inner tube
receiving a respective one of the guide lines for translation with
respect thereto.
44. The implant kit of claim 43 wherein the distal end of the inner
tube is in butting engagement with a portion of a respective one of
the tissue anchors until the inner tube is withdrawn from the
tissue anchor after the tissue anchor has been embedded in the
tissue.
45. The implant kit of claim 43 wherein the tissue anchors each
comprise at least one resilient barb, the at least one resilient
barb protectively retained in the inner tube lumen of the inner
tube until the inner tube is withdrawn from the tissue anchor after
the tissue anchor has been embedded in the tissue.
46. The implant kit of claim 43 wherein the outer tube of each of
the anchor guide arms further has a second outer tube lumen; and
the anchor guide frame further comprises a plurality of arms, each
of the arms received in the second outer tube lumen of a respective
one of the anchor guide arms.
47. The implant kit of claim 29 wherein the implant member has at
least three guide line receivers that each ride on respective ones
of the guide lines, wherein a circumference defined by a circle
passing through at least three locations of the at least three
guide line receivers on the implant member in the deployed
configuration is smaller than a circumference defined by a circle
passing through at least three locations of the embedded tissue
anchors in the tissue prior to a physical coupling between the
implant member and the embedded tissue anchors.
48. The implant kit of claim 29 wherein the implant member has at
least three guide line receivers that each ride on respective ones
of the guide lines, wherein a circumference defined by a circle
passing through at least three locations of the at least three
guide line receivers on the implant member in the deployed
configuration is smaller than a circumference of an annulus of the
orifice in the tissue prior to a physical coupling between the
implant member and the embedded tissue anchors.
49. The implant kit of claim 29 wherein the implant member has at
least three tissue anchor receivers, each of the tissue anchor
receivers positioned to physically couple with a respective one of
the plurality of tissue anchors, wherein a circumference defined by
a circle passing through at least three locations of the at least
three tissue anchor receivers on the implant member in the deployed
configuration is smaller than a circumference defined by a circle
passing through at least three locations of the embedded tissue
anchors in the tissue prior to a physical coupling between the
implant member and the embedded tissue anchors.
50. The implant kit of claim 29 wherein at least one of the tissue
anchors comprises a helical tissue anchor.
51. The implant kit of claim 29 wherein the at least one of the
tissue anchors comprises a grapple tissue anchor that includes at
least two prongs pivotally coupled to each other, each of the two
prongs having a tip shaped to pierce the tissue.
52. The implant kit of claim 29, further comprising a plurality of
fasteners, each fastener movable along a respective one of the
guide lines to a position where at least some of the fasteners
secure the implant member to the tissue under tension in the
deployed configuration.
53. The implant kit of claim 52 wherein each of the fasteners
comprises a unidirectional clutch that in use allows the fastener
to advance along a respective one of the guide lines toward a
respective one of the embedded tissue anchors and prevents the
fastener from retreating along the guide line away from the
respective embedded tissue anchor.
54. The implant kit of claim 52 wherein the plurality of fasteners
and the implant member are provided in a unitary structure.
55. The implant kit of claim 52 wherein the at least some of the
fasteners are each fastenable to a respective one of the guide
lines to secure the implant member to the tissue under tension in
the deployed configuration.
56. The implant kit of claim 52 wherein the at least some of the
fasteners are each fastenable to a respective one of the embedded
tissue anchors to secure the implant member to the tissue under
tension in the deployed configuration.
57. The implant kit of claim 29 wherein the implant member includes
a plurality of receivers, each of the receivers having at least one
of the guidelines passing therethrough, where all of the guidelines
passing through a respective one of the receivers extend to a
single respective one of the tissue anchors embedded in the
tissue.
58. A method of operating a medical device system to constrict an
orifice in tissue, the method comprising: positioning a tool having
a guide frame with a plurality of guide members such that distal
ends of the guide members are at least proximate respective
locations about a periphery of an orifice in a tissue internally
within a body; actuating the guide members to embed a plurality of
tissue anchors in the tissue at least proximate respective ones of
the respective locations about the periphery of the orifice in the
tissue; advancing an annuloplasty implant member to the tissue
along a plurality of guide lines that extend from the embedded
tissue anchors; and securing the annuloplasty implant member to the
embedded tissue anchors via a plurality of fasteners, the
annuloplasty implant secured in an anchored configuration.
59. The method of claim 58, further comprising: percutaneously
delivering the guide frame into the body in a compressed
configuration; expanding the guide frame into an uncompressed
configuration before positioning the tool such that the distal ends
of the guide members are at least proximate their respective
locations about the periphery of the orifice; compressing the guide
frame after actuating the guide members to embed the plurality of
tissue anchors; and percutaneously removing the guide frame from
the body after compressing the guide frame.
60. The method of claim 59, further comprising: percutaneously
delivering the annuloplasty implant member into the body in an
unanchored configuration after percutaneously removing the guide
frame from the body.
61. The method of claim 60 wherein securing the annuloplasty
implant member to the embedded tissue anchors via a plurality of
fasteners, the annuloplasty implant secured in an anchored
configuration comprises securing the annuloplasty implant member in
an arch shape anchored proximate each of two ends, and proximate a
location between the two ends, and percutaneously delivering the
annuloplasty implant member into the body in an unanchored
configuration comprises percutaneously delivering the annuloplasty
implant member in an elongated scallop shape.
62. The method of claim 60, further comprising passing the guide
lines through respective ones of a number of guide line receivers
of the annuloplasty implant member before percutaneously delivering
the annuloplasty implant member into the body in an unanchored
configuration.
63. The method of claim 62 wherein actuating the guide members to
embed a plurality of tissue anchors in the tissue at least
proximate respective ones of the respective locations about the
periphery of the orifice in the tissue comprises embedding the
tissue anchors such that a circumference defined by a circle
passing through at least three locations of respective ones of the
tissue anchors embedded about the periphery of the orifice in the
tissue is greater than a circumference defined by a circle passing
through at least three locations of the guide line receivers on the
annuloplasty member in the anchored configuration.
64. The method of claim 58 wherein actuating the guide members to
embed a plurality of tissue anchors in the tissue comprises
actuating the guide members to embed the plurality of tissue
anchors having respective ones of the guide lines extending
therefrom in the tissue.
65. The method of claim 58 wherein securing the annuloplasty
implant member to the embedded tissue anchors via a plurality of
fasteners, the annuloplasty implant secured in an anchored
configuration comprises advancing each fastener along a respective
one of the guide lines into contact with a respective portion of
the annuloplasty implant member.
66. The method of claim 58 wherein securing the annuloplasty
implant member to the embedded tissue anchors via a plurality of
fasteners, the annuloplasty implant secured in an anchored
configuration comprises advancing each fastener having a
unidirectional clutch along a respective one of the guide
lines.
67. The method of claim 58 wherein actuating the guide members to
embed a plurality of tissue anchors in the tissue at least
proximate respective ones of the respective locations about the
periphery of the orifice in the tissue comprises extending a
respective inner tube of each of the guide members from a lumen of
a respective outer tube of each of the guide members, the inner
tube advancing a respective one of the tissue anchors into the
tissue.
68. The method of claim 67, further comprising withdrawing the
inner tube of each of the guide members away from a respective one
of the tissue anchors embedded in the tissue to expose at least one
barb of the tissue anchor to the tissue.
69. The method of claim 67, further comprising retracting the inner
tube of each of the guide members into the lumen of the outer tube
of the respective one of the guide members while at least
maintaining a position of the guide wire extending from a
respective one of the tissue anchors with respect to the tissue.
Description
RELATED APPLICATIONS
[0001] This application claims benefit under 35 U.S.C. 119(e) to
U.S. provisional patent application Ser. No. 61/278,232, filed Oct.
1, 2009.
BACKGROUND
[0002] 1. Field
[0003] This disclosure is generally related to percutaneous or
minimally invasive surgery, and more particularly to percutaneously
deployed medical devices suitable for constricting tissue or a
bodily orifice, such as a mitral valve.
[0004] 2. Description of the Related Art
[0005] Cardiac surgery was initially undertaken only by performing
a sternotomy, a type of incision in the center of the chest, which
separates the sternum (chest bone) to allow access to the heart. In
the previous several decades, more and more cardiac operations are
performed using a percutaneous technique, which is a medical
procedure where access to inner organs or other tissue is gained
via a catheter.
[0006] Percutaneous surgeries benefit patients by reducing surgery
risk, complications, and recovery time. However, the use of
percutaneous technologies also raises some particular challenges.
Medical devices used in percutaneous surgery need to be deployed
via narrow tubes called catheter sheaths, which significantly
increase the complexity of the device structure. As well, doctors
do not have direct visual contact with the medical tools used once
they are placed within the body, and positioning the tools
correctly and operating the tools successfully can often be very
challenging. Various catheters can be deployed through a catheter
sheath in percutaneous surgical applications.
[0007] One example of where percutaneous medical techniques are
starting to be used is in the treatment of a heart disorder called
mitral regurgitation. Mitral regurgitation is a condition in which
blood flows backward from the left ventricle into the left atrium.
The mitral apparatus is made up of four major structural components
and includes the annulus, the two leaflets, the chordae and the
papillary muscles. Improper function of any one of these
structures, alone or in combination can lead to mitral
regurgitation. Annular dilation is a major component in the
pathology of mitral regurgitation regardless of cause and is
manifested in mitral regurgitation related to dilated
cardiomyopathy and chronic mitral regurgitation due to
ischemia.
[0008] The mitral valve is intended to prevent the undesired flow
of blood from the left ventricle into the left atrium when the left
ventricle contracts. In a normal mitral valve, the geometry of the
mitral valve ensures the cusps overlay each other to preclude the
regurgitation of blood during left ventricular contraction and
thereby prevent elevation of pulmonary vascular pressures and
resultant symptoms of shortness of breath. Studies of the natural
history of mitral regurgitation have found that totally
asymptomatic patients with severe mitral insufficiency usually
progress to severe disability within 5 years.
[0009] At present, treatment consists of either mitral valve
replacement or repair. Both methods require open heart surgery.
Replacement can be performed with either mechanical or biological
valves and is particularly suitable when one of the mitral cusps
has been severely damaged or deformed. The mechanical valve carries
the risk of thromboembolism and requires anticoagulation with all
of its potential hazards, whereas the biological prosthesis suffers
from limited durability. Another hazard with replacement is the
risk of endocarditis. These risks and other valve related
complications are greatly diminished with valve repair. Mitral
valve repair is theoretically possible if the mitral valve leaflets
are structurally normal but fail to appropriately coapt because of
annular dilatation and/or papillary muscle dysfunction. Various
surgical procedures have been developed to improve coaptation of
the leaflet and to correct the deformation of the mitral valve
annulus and retain the intact natural heart valve function. These
procedures generally involve reducing the circumference of the
posterior mitral leaflet annulus (lateral annulus) where most of
the dilatation occurs. The annulus of the anterior leaflet (septal
annulus) does not generally dilate because it is anchored to the
fibrous skeleton at the base of the heart. Such techniques, known
as mitral annuloplasty, typically suture a prosthesis around the
base of the valve leaflets shortening the lateral annulus to
reshape the mitral valve annulus and minimize further dilation.
Different types of mitral annuloplasty prostheses have been
developed for use in such surgery. In general, such prostheses are
annular or partially annular shaped and may be formed from rigid or
flexible material.
[0010] Mitral valve surgery requires an extremely invasive approach
that includes a chest wall incision, cardiopulmonary bypass,
cardiac and pulmonary arrest, and an incision on the heart itself
to gain access to the mitral valve. Such a procedure is expensive,
requires considerable time, and is associated with high morbidity
and mortality. Due to the risks associated with this procedure,
many of the sickest patients are denied the potential benefits of
surgical correction of mitral regurgitation. In addition, patients
with moderate, symptomatic mitral regurgitation are denied early
intervention and undergo surgical correction only after the
development of cardiac dysfunction. Furthermore, the effectiveness
of such procedures is difficult to assess during the procedure and
may not be known until a much later time. Hence, the ability to
make adjustments to or changes in the prosthesis function to obtain
optimum effectiveness is extremely limited. Correction at a later
date would require another open heart procedure.
[0011] In an attempt to treat mitral regurgitation without the need
for cardiopulmonary bypass and without opening the chest,
percutaneous approaches have been devised to repair the valve or
place a correcting apparatus for correcting the annulus relaxation.
Such approaches make use of devices which can be generally grouped
into two types: 1) devices deforming (mainly shortening) the
coronary sinus; and 2) devices pulling together two anchor points
in order to affect the mitral valve, one of the anchor points can
be the coronary sinus (typically using a wire that is pulled and
secured).
[0012] Neither approach emulates the current "gold standard" in
mitral valve repair--annuloplasty using an open or closed ring.
Both approaches suffer from several problems as a result of
attempting to reshape the mitral annulus using an alternative
method. Devices that deform the coronary sinus, while suitable for
percutaneous procedures, are not effective in controlling the
leakage of the mitral valve as the forces are not applied from the
correct opposite sides of the valve, which are the lateral annulus
and the septal annulus. The devices of the second type are not
easily adapted to a percutaneous procedure. In order to achieve
shortening in the direction connecting the lateral annulus to the
septal annulus the anchor points have to be located along this
line, so pulling them together will affect the desired direction of
shortening. Pulling applied along a different direction will
distort the mitral valve but will not achieve the optimal
approximation of the two leaflets.
[0013] Thus, there is a need for methods and apparatus that enable
the ability to create a mitral annuloplasty that applies forces
from various desired directions via a percutaneous or intravascular
procedure.
BRIEF SUMMARY
[0014] The subject of the present application is a medical device
with enhanced capabilities for percutaneous deployment and annulus
shape modification and a superior method for constricting tissue or
a bodily orifice, such as the mitral valve, tricuspid valve, or
aortic valve via such device. The device may enable methods that
enable a closed or open (i.e., split) ring to be anchored to tissue
in the vicinity of an orifice or annulus and may enable a change in
the shape of said annulus by the anchored ring. Reference
throughout this specification is made to cardiac surgery, but the
methods and apparatus described herein may also be used in gastric
surgery, bowel surgery, or other surgeries in which tissue may be
drawn together. The methods and apparatus described herein may also
be used to draw or hold tissue not part of an orifice or annulus
together. The methods and apparatus described herein may be used in
minimally invasive surgery as well as intravascular or percutaneous
surgery. Other advantages will become apparent from the teaching
herein to those of skill in the art.
[0015] An implant kit may be summarized as including a plurality of
tissue anchors comprising at least a first tissue anchor, a second
tissue anchor and a third tissue anchor; a percutaneous delivery
system operable to at least partially embed each of the tissue
anchors into a respective location about a periphery of an orifice
in a tissue within a body during an implant procedure in which a
location of the embedded third tissue anchor is laterally offset by
a first distance from a first axis, the first axis extending
between a location of the embedded first tissue anchor and a
location of the embedded second tissue anchor; an implant member
reconfigurable between a delivery configuration in which the
implant member is manipulable to a size and dimension to be
deliverable percutaneously to the tissue within the body, and an
implantable configuration in which the implantable member forms a
structure sufficiently rigid to affect a shape of the orifice in
the tissue, the implant member further comprising a plurality of
tissue anchor receivers, each of the tissue anchor receivers
positioned to physically couple with a respective one of the
embedded tissue anchors, the plurality of tissue anchor receivers
comprising at least a first tissue anchor receiver corresponding to
the first tissue anchor, a second tissue anchor receiver
corresponding to the second tissue anchor, and a third tissue
anchor receiver corresponding to the third tissue anchor, wherein a
location of the third tissue anchor receiver on the implant member
in the implantable configuration is laterally offset by a second
distance from a second axis, the second axis extending between a
location of the first tissue anchor receiver on the implant member
and a location of the second tissue anchor receiver on the implant
member, wherein the second distance is smaller than the first
distance; and a plurality of implant guide lines that in use during
the implant procedure provide a physical path for the implant
member to the embedded tissue anchors.
[0016] The implant member may include a plurality of segments
physically coupled to one another, the segments being articuable
with respect to one another as the implant member is moved between
the deliverable configuration and the implantable configuration.
The implant member may include a number of hinges that physically
couple each of the segments to at least one other of the segments.
The implant member may include a number of stops configured to
increase a torsional stiffness of each of the hinges when each of
the segments pivots by a defined amount with respect to another of
the segments. The implant member may include a number of flexure
joints that physically couple each of the segments to at least one
other of the segments. The implant member may include a number of
stops configured to increase a bending stiffness of each of the
flexure joints when each of the segments flexes by a defined amount
with respect to another of the segments. The implant member may
include a number of stops configured to restrain articulation
between the coupled segments.
[0017] Each of the tissue anchors may include at least one barb.
Each of the tissue anchors may be a helical tissue anchor. Each of
the tissue anchors may be a grapple tissue anchor, each grapple
tissue anchor may include at least two prongs pivotally coupled to
each other, and each of the two prongs may have a tip shaped to
pierce the tissue.
[0018] The implant member may have at least three guide line
receivers that each ride on respective ones of the guide lines,
wherein a circumference defined by a circle passing through at
least three locations of the at least three guide line receivers on
the implant member in the implantable configuration may be smaller
than a circumference defined by a circle passing through the
respective locations of the embedded first, second and third tissue
anchors prior to a physical coupling between each of the embedded
first, second and third tissue anchors and respective ones of the
first, second and third tissue anchor receivers.
[0019] An implant kit may be summarized as including an implant
member configured to affect a shape of an orifice in tissue within
a body during an implant procedure, a portion of the implant member
having a variable bending stiffness in at least one dimensional
plane, the implant member comprising a first end, a second end and
a plurality of guide line receivers positioned between the first
end and the second end along the implant member, the implant member
configured to be bendable between a first configuration in which
implant member has an elongated shape and a second configuration in
which the implant has an arcuate shape, the first end being spaced
apart from the second end by a greater distance when the implant
member is in the first configuration than when the implant member
is in the second configuration, and the portion of the implant
member having a reduced bending stiffness in the at least one
dimensional plane when the implant member is in first configuration
and an increased bending stiffness in the at least one dimensional
plane when the implant member is in the second configuration; a
plurality of tissue anchors configured to be at least partially
embedded into tissue at respective locations about the orifice in
the tissue within the body; and a plurality of guide lines, each of
the guide lines sized to be received by a respective one of the
guide line receivers and a respective one of the tissue anchors,
each of at least one of the guide lines being configured to receive
a tensile force sufficient to move a portion of the tissue into
which a respective tissue anchor is embedded towards the implant
member in the second configuration.
[0020] The implant member may include a plurality of tissue anchor
receivers positioned along the implant member between the first end
and the second end, each of the tissue anchor receivers configured
to physically receive a respective one of the tissue anchors, and
wherein each of the at least one of the guide lines may be
configured to receive a tensile force sufficient to move the
portion of the tissue to a position where the respective tissue
anchor embedded into the portion of the tissue is physically
received by a respective tissue anchor receiver when the implant
member in the second configuration.
[0021] The implant member may include a plurality of segments
physically coupled to one another, the segments being articuable
with respect to one another to provide the reduced bending
stiffness in the at least one dimensional plane when the implant
member is in the first configuration. The implant member may
include a number of hinges that physically couple each of the
segments to at least one other of the segments. The implant member
may include a number of stops configured to increase a torsional
stiffness of each of the hinges when each of the segments pivots by
a defined amount with respect to another of the segments to provide
the increased bending stiffness in the at least one dimensional
plane when the implant member is in the second configuration. The
implant member may include a number of flexure joints that
physically couple each of the segments to at least one other of the
segments. The implant member may include a number of stops
configured to provide the increased bending stiffness in the at
least one dimensional plane when the implant member is in the
second configuration. The implant member may include a number of
stops configured to restrain articulation between the coupled
segments to provide the increased bending stiffness in the at least
one dimensional plane when the implant member is in the second
configuration.
[0022] The embedded tissue anchors may apply tension to implant
member in the second configuration when each of the tissue anchor
receivers is coupled with a respective one of the embedded tissue
anchors. The applied tension may be sufficient to restrain
disengagement of each of the coupled segments with an associated
one of the stops. The applied tension may be sufficient to flex at
least one of segments while each of the at least one of the
segments is engaged with an associated one of the stops.
[0023] Each of the tissue anchors may include at least one piercing
element configured for piercing the tissue. Each of the tissue
anchors may be a helical tissue anchor. Each of the tissue anchors
may be a grapple tissue anchor, each grapple tissue anchor may
include at least two prongs pivotally coupled to each other, and
each of the two prongs may have a tip shaped to pierce the tissue.
The plurality of guide line receivers may include at least three
guide line receivers, a circumference defined by a circle passing
through at least three locations of the at least three guide line
receivers on the implant member in the second configuration being
smaller than a circumference defined by a circle passing through at
least three locations of their respective embedded tissue anchors
about the orifice in the tissue prior to a physical coupling
between any of the tissue anchor receivers and their respective
embedded tissue anchors.
[0024] The implant member in the first configuration may be
manipulable to a size and dimension to be deliverable via a
catheter. The portion of the implant member may have a
substantially equal bending stiffness in each of a plurality of
directions in the at least one dimensional plane when the implant
member is in the first configuration and the portion of the implant
member may have a substantially unequally bending stiffness in each
of the plurality of directions in the at least one dimensional
plane when the implant member is in the second configuration.
[0025] An implant kit may be summarized as including a plurality of
tissue anchors configured to be at least partially embedded into
tissue at respective locations about an orifice in the tissue
during an implant procedure; an implant member having a plurality
of segments physically coupled to one another, in a delivery
configuration the segments being articulable with respect to one
another by a respective articulation joint such that the implant
member is manipulable to a size and dimension to be deliverable via
a catheter and in an deployed configuration the segments form a
structure sufficiently rigid to affect a shape of the orifice in
the tissue when the implant member is positioned to physically
couple with the embedded tissue anchors; and a plurality of implant
guide lines that in use during the implant procedure provide a
physical path for the implant member to respective ones of the
embedded tissue anchors, the implant member moveable along the
physical path to a position where the implant member is secured to
the tissue under tension in the deployed configuration.
[0026] The tissue anchors and respective ones of the guide lines
may be integral structures comprised of at least one of a metal
wire. The tissue anchors and respective ones of the guide lines may
be unitary structures, each of the tissue anchors may include at
least one piercing element at a distal end of a respective one of
the guide lines, wherein the at least one piercing element may be
configured to pierce the tissue. The structure formed by the
segments of the implant member may have a C-shape profile.
[0027] The implant kit may further include an implant cross
connector attachable across an open portion of the implant member
such that when attached, the implant cross connector and the
structure formed by the segments of the implant member have a
D-shape profile.
[0028] The implant member may have a number of guide line receivers
that ride on respective ones of the guide lines. The implant member
may have at least three guide line receivers, at least a first
guide line receiver proximate a first end of the implant member, a
second guide line receiver proximate a second end of the implant
member, and a third guide line receiver positioned along the
structure formed by the segments between the first and the second
guide line receivers.
[0029] The respective articulation joint of the implant member may
include a number of hinges that physically couple each of the
segments of the implant member to at least one other of the
segments of the implant member.
[0030] The implant member may include a number of stops configured
to limit a travel of each of the segments of the implant member
with respect to another of the segments of the implant member. The
implant member may include a number of stops configured to increase
a torsional stiffness of each of the hinges when each of the
segments of the implant member pivots by a defined amount with
respect to another of the segments of the implant member.
[0031] The respective articulation joint of the implant member may
include a number of flexure joints that physically couple each of
the segments of the implant member to at least one other of the
segments of the implant member.
[0032] The implant member may include a number of stops configured
to limit a travel of each of the segments of the implant member
with respect to another of the segments of the implant member. The
implant member may include a number of stops configured to increase
a bending stiffness of each of the flexure joints when each of the
segments of the implant member flexes by a defined amount with
respect to another of the segments of the implant member.
[0033] The implant kit may further include an anchor guide frame
having at least three anchor guide arms, wherein each of the tissue
anchors may be configured to be physically releasably guided by a
respective one of the anchor guide arms of the anchor guide frame
to a respective location on an annulus about the orifice in the
tissue and embedded in the annulus at least proximate the
respective locations.
[0034] The anchor guide arms may each include an outer tube having
at least a first outer tube lumen, and an inner tube having an
inner tube lumen, the inner tube received in the first outer tube
lumen of the outer tube for translational movement between a
retracted position in which a distal end of the inner tube does not
extend beyond a distal end of the first outer tube lumen and an
extended position in which the distal end of the inner tube extends
beyond the distal end of the first outer tube lumen, the inner tube
lumen of the inner tube receiving a respective one of the guide
lines for translation with respect thereto.
[0035] The distal end of the inner tube may be in butting
engagement with a portion of a respective one of the tissue anchors
until the inner tube is withdrawn from the tissue anchor after the
tissue anchor has been embedded in the tissue.
[0036] The tissue anchors may each include at least one resilient
barb, the at least one resilient barb protectively retained in the
inner tube lumen of the inner tube until the inner tube is
withdrawn from the tissue anchor after the tissue anchor has been
embedded in the tissue.
[0037] The outer tube of each of the anchor guide arms may further
have a second outer tube lumen; and the anchor guide frame may
further include a plurality of arms, each of the arms received in
the second outer tube lumen of a respective one of the anchor guide
arms.
[0038] The implant member may have at least three guide line
receivers that each ride on respective ones of the guide lines,
wherein a circumference defined by a circle passing through at
least three locations of the at least three guide line receivers on
the implant member in the deployed configuration may be smaller
than a circumference defined by a circle passing through at least
three locations of the embedded tissue anchors in the tissue prior
to a physical coupling between the implant member and the embedded
tissue anchors.
[0039] The implant member may have at least three guide line
receivers that each ride on respective ones of the guide lines,
wherein a circumference defined by a circle passing through at
least three locations of the at least three guide line receivers on
the implant member in the deployed configuration may be smaller
than a circumference of an annulus of the orifice in the tissue
prior to a physical coupling between the implant member and the
embedded tissue anchors.
[0040] The implant member may have at least three tissue anchor
receivers, each of the tissue anchor receivers positioned to
physically couple with a respective one of the plurality of tissue
anchors, wherein a circumference defined by a circle passing
through at least three locations of the at least three tissue
anchor receivers on the implant member in the deployed
configuration may be smaller than a circumference defined by a
circle passing through at least three locations of the embedded
tissue anchors in the tissue prior to a physical coupling between
the implant member and the embedded tissue anchors.
[0041] At least one of the tissue anchors may include a helical
tissue anchor. The at least one of the tissue anchors may include a
grapple tissue anchor that may include at least two prongs
pivotally coupled to each other, each of the two prongs having a
tip shaped to pierce the tissue.
[0042] The implant kit may further include a plurality of
fasteners, each fastener movable along a respective one of the
guide lines to a position where at least some of the fasteners
secure the implant member to the tissue under tension in the
deployed configuration. Each of the fasteners may include a
unidirectional clutch that in use allows the fastener to advance
along a respective one of the guide lines toward a respective one
of the embedded tissue anchors and prevents the fastener from
retreating along the guide line away from the respective embedded
tissue anchor. The plurality of fasteners and the implant member
may be provided in a unitary structure. The at least some of the
fasteners may each be fastenable to a respective one of the guide
lines to secure the implant member to the tissue under tension in
the deployed configuration. The at least some of the fasteners may
each be fastenable to a respective one of the embedded tissue
anchors to secure the implant member to the tissue under tension in
the deployed configuration.
[0043] The implant member may include a plurality of receivers,
each of the receivers having at least one of the guidelines passing
therethrough, where all of the guidelines passing through a
respective one of the receivers extend to a single respective one
of the tissue anchors embedded in the tissue.
[0044] A tissue anchor system for securing an implant member to
tissue within a body during an implant procedure may be summarized
as including a tissue anchor comprising plurality of elongated
members, each of the elongated members comprising a first end, a
second end and an intermediate portion positioned between the first
and the second ends, wherein each of the second ends comprises a
tip shaped to penetrate the tissue, and the intermediate portions
of at least two of the elongate members are pivotably coupled
together by a pivot member; and at least one coupler physically
coupled to at least one of the elongated members at location on a
portion of the at least one of the elongated members extending
between the pivot point and the first end of the at least one of
the elongated members, the coupler configured to securely couple
the tissue anchor to the implant member during the implant
procedure.
[0045] Each elongated member of the at least two elongated members
may include an arcuate shaped portion. Each elongated member of the
at least two elongated members may include a portion between the
pivot point and the second end of the elongated member that extends
along an arcuate path. Each of the second ends may include a barb.
The at least one coupler may be physically coupled to each of the
at least two elongated members. The at least one coupler may
include a flexible line sized to be received through an opening
provided in an elongated member of the at least two elongated
members. The at least one coupler may include a flexible line sized
to be received through a respective opening provided in each
elongated member of the at least two elongated members. The at
least one coupler may include a plurality of a flexible lines, each
of the flexible lines sized to be received through an opening
provided in an elongated member of the at least two elongated
members. The at least one coupler and the at least one elongated
member may be a unitary structure. The at least one coupler may
include a flexible line sized to be received though an opening
provided in the at least one elongated member and through an
opening provided in the implant member.
[0046] An opening may be provided in each of one or more of the
elongated members, each opening sized to receive a guide line
therethrough.
[0047] The at least one coupler may include a clamp configured to
clamp a portion of the implant member. The at least one coupler may
include an extension sized to be received within an opening
provided in the implant member. The at least one coupler may
include an expansion member configured to expand and grip one or
more surfaces of the implant member. The at least one coupler may
include a contraction member configured to contract and grip one or
more surfaces of the implant member. The at least one coupler may
include a detent. Each of the tissue anchor and the coupler may be
sized to be delivered percutaneously to the tissue in the body
during the implant procedure.
[0048] A method of operating a medical device system to constrict
an orifice in tissue may be summarized as including positioning a
tool having a guide frame with a plurality of guide members such
that distal ends of the guide members are at least proximate
respective locations about a periphery of an orifice in a tissue
internally within a body; actuating the guide members to embed a
plurality of tissue anchors in the tissue at least proximate
respective ones of the respective locations about the periphery of
the orifice in the tissue; advancing an annuloplasty implant member
to the tissue along a plurality of guide lines that extend from the
embedded tissue anchors; and securing the annuloplasty implant
member to the embedded tissue anchors via a plurality of fasteners,
the annuloplasty implant secured in an anchored configuration.
[0049] The method of operating a medical device system to constrict
an orifice in tissue may further include percutaneously delivering
the guide frame into the body in a compressed configuration;
expanding the guide frame into an uncompressed configuration before
positioning the tool such that the distal ends of the guide members
are at least proximate their respective locations about the
periphery of the orifice; compressing the guide frame after
actuating the guide members to embed the plurality of tissue
anchors; and percutaneously removing the guide frame from the body
after compressing the guide frame.
[0050] The method of operating a medical device system to constrict
an orifice in tissue may further include percutaneously delivering
the annuloplasty implant member into the body in an unanchored
configuration after percutaneously removing the guide frame from
the body.
[0051] Securing the annuloplasty implant member to the embedded
tissue anchors via a plurality of fasteners, the annuloplasty
implant secured in an anchored configuration may include securing
the annuloplasty implant member in an arch shape anchored proximate
each of two ends, and proximate a location between the two ends,
and percutaneously delivering the annuloplasty implant member into
the body in an unanchored configuration comprises percutaneously
delivering the annuloplasty implant member in an elongated scallop
shape.
[0052] The method of operating a medical device system to constrict
an orifice in tissue may further include passing the guide lines
through respective ones of a number of guide line receivers of the
annuloplasty implant member before percutaneously delivering the
annuloplasty implant member into the body in an unanchored
configuration.
[0053] Actuating the guide members to embed a plurality of tissue
anchors in the tissue at least proximate respective ones of the
respective locations about the periphery of the orifice in the
tissue may include embedding the tissue anchors such that a
circumference defined by a circle passing through at least three
locations of respective ones of the tissue anchors embedded about
the periphery of the orifice in the tissue is greater than a
circumference defined by a circle passing through at least three
locations of the guide line receivers on the annuloplasty member in
the anchored configuration. Actuating the guide members to embed a
plurality of tissue anchors in the tissue may include actuating the
guide members to embed the plurality of tissue anchors having
respective ones of the guide lines extending therefrom in the
tissue.
[0054] Securing the annuloplasty implant member to the embedded
tissue anchors via a plurality of fasteners, the annuloplasty
implant secured in an anchored configuration may include advancing
each fastener along a respective one of the guide lines into
contact with a respective portion of the annuloplasty implant
member. Securing the annuloplasty implant member to the embedded
tissue anchors via a plurality of fasteners, the annuloplasty
implant secured in an anchored configuration may include advancing
each fastener having a unidirectional clutch along a respective one
of the guide lines.
[0055] Actuating the guide members to embed a plurality of tissue
anchors in the tissue at least proximate respective ones of the
respective locations about the periphery of the orifice in the
tissue may include extending a respective inner tube of each of the
guide members from a lumen of a respective outer tube of each of
the guide members, the inner tube advancing a respective one of the
tissue anchors into the tissue.
[0056] The method of operating a medical device system to constrict
an orifice in tissue may further include withdrawing the inner tube
of each of the guide members away from a respective one of the
tissue anchors embedded in the tissue to expose at least one barb
of the tissue anchor to the tissue.
[0057] The method of operating a medical device system to constrict
an orifice in tissue may further include retracting the inner tube
of each of the guide members into the lumen of the outer tube of
the respective one of the guide members while at least maintaining
a position of the guide wire extending from a respective one of the
tissue anchors with respect to the tissue.
[0058] An annuloplasty implant may be summarized as including at
least three arcuate segments coupled to one another by respective
ones of a number of articulation joints to form an articulated
structure, each of the arcuate segments arcuate about a respective
axis, the articulated structure having a first end and a second
end, a first guide line receiver proximate the first end, a second
guide line receiver proximate the second end, and at least a third
guide line receiver between the first and the second guide line
receivers, the first, the second and at least the third guide line
receivers each sized to receive a respective guide line to a
respective tissue anchor, the articulated structure configurable
between an anchored configuration in which the arcuate segments are
arranged with respect to one another in an arcuate shape structure
which is arcuate about an axis that is parallel to the respective
axes of the arcuate segments, the arcuate shape structure having an
anchored maximum longitudinal dimension and an anchored maximum
lateral dimension, and an unanchored configuration in which the
arcuate segments are arranged with respect to one another in an
elongated scallop shape structure that has an unanchored maximum
longitudinal dimension and an unanchored maximum lateral dimension,
the unanchored maximum longitudinal dimension greater than the
anchored maximum longitudinal dimension and the anchored maximum
lateral dimension greater than the unanchored maximum lateral
dimension.
[0059] The articulation joints may be hinges that pivotally couple
successively neighboring ones of the arcuate segments together in
at least the unanchored configuration. The arcuate segments may
each include a stop that interacts with a complimentary stop on an
adjacent one of the arcuate segments. A pin of each hinge may be
offset from a longitudinal centerline of at least one of the
arcuate segments coupled by the hinge. The articulation joints may
be flexure joints that pivotally couple successively neighboring
ones of the arcuate segments together in at least the unanchored
configuration. At least one respective recess between each pair of
adjacent ones of the arcuate segments may define each of the
respective flexure joints.
[0060] The arcuate segments may be configured to be mounted
directly to tissue comprising a mitral valve via a plurality of
tissue anchors and guide lines that apply force to at least some of
the arcuate segments as the annuloplasty implant transitions from
the unanchored configuration to the anchored configuration, the
articulated structure sufficiently rigid when in the anchored
configuration to affect a shape of the mitral valve.
[0061] The annuloplasty implant may further include at least three
fasteners, the fasteners each having an aperture sized to receive a
respective guide line, and the fasteners sized to not be received
through the guide line receivers of the arcuate segments.
[0062] The arcuate segments may include at least one of a textured
surface, a tissue scaffold or a therapeutic eluting layer. The
articulated structure may be configured to be coupled directly to a
plurality of tissue anchors embedded in tissue comprising an
orifice, and wherein the articulated structure may include at least
three tissue anchor receivers, each of the at least three tissue
anchor receivers configured to physically couple with a respective
one of the tissue anchors, and wherein a circumference defined by a
circle passing through at least three locations of the at least
three tissue anchor receivers on the articulated structure in the
anchored configuration is smaller than a circumference defined by a
circle passing through at least three locations of the embedded
tissue anchors in the tissue prior to a physical coupling between
the articulated structure and the embedded tissue anchors.
[0063] Various systems and methods may include combinations and
subsets of those summarized above.
BRIEF DESCRIPTION OF THE DRAWINGS
[0064] In the drawings, identical reference numbers identify
similar elements or acts. The sizes and relative positions of
elements in the drawings are not necessarily drawn to scale. For
example, the shapes of various elements and angles are not drawn to
scale, and some of these elements are arbitrarily enlarged and
positioned to improve drawing legibility. Further, the particular
shapes of the elements as drawn, are not intended to convey any
information regarding the actual shape of the particular elements,
and have been solely selected for ease of recognition in the
drawings.
[0065] FIG. 1 is a schematic diagram of a medical device system
according to one illustrated embodiment, including an implantable
device and a tool with a control handle, tissue anchors, and anchor
guide mechanism that is operable to implant the implantable
device.
[0066] FIG. 2 is a cutaway diagram of a heart showing an
implantable medical device implanted in tissue therein according to
one illustrated embodiment, the implantable device percutaneously
placed in a left atrium of the heart.
[0067] FIG. 3 is a diagram showing an example of a helical tissue
anchor according to one illustrated embodiment.
[0068] FIG. 4A is an isometric partial view showing an example of a
multi-barbed tissue anchor with resilient barbs retained by a
constriction tube according to one illustrated embodiment.
[0069] FIG. 4B is an isometric partial view showing an example of a
multi-barbed anchor with the resilient barbs free of the
constriction tube and exposed.
[0070] FIG. 5A is front elevational view showing a helical tissue
anchor embedded in tissue according to one illustrated
embodiment.
[0071] FIG. 5B is front elevational view showing a barbed tissue
anchor embedded in tissue according to one illustrated
embodiment.
[0072] FIG. 5C is front elevational view showing a barbed tissue
anchor with an integral guide line such as a guide wire according
to another illustrated embodiment, the tissue anchor embedded in
tissue.
[0073] FIG. 5D is front elevational view showing a barbed tissue
anchor with a unitary guide line such as a guide wire according to
a further illustrated embodiment, the tissue anchor embedded in
tissue.
[0074] FIG. 5E is front elevational view showing a grapple tissue
anchor embedded in tissue according to one illustrated
embodiment.
[0075] FIG. 6A is an elevational view showing a tissue anchor
movably received on a guided member according to one illustrated
embodiment.
[0076] FIG. 6B is an elevational view showing a tissue anchor
movably received on a guided rail according to another illustrated
embodiment.
[0077] FIGS. 7A-7C are sequential elevational views showing a
helical tissue anchor movably received on a guided member
penetrating tissue at three successive intervals of time according
to one illustrated embodiment.
[0078] FIGS. 8A and 8B are sequential elevational views showing a
multi-barbed tissue anchor movably received on a guided member
penetrating tissue at two successive intervals of time according to
one illustrated embodiment.
[0079] FIGS. 8C through 8F are sequential elevational views showing
a multi-barbed tissue anchor movably guided via a guided member
penetrating tissue at four successive intervals of time according
to one illustrated embodiment.
[0080] FIG. 9 is an isometric view of an anchor guide frame
according to one illustrated embodiment.
[0081] FIG. 10 is a side elevational view of an anchor guide frame
compressed into a sheath according to one illustrated
embodiment.
[0082] FIG. 11 is an isometric view of an expanded anchor guide
frame according to one illustrated embodiment.
[0083] FIG. 12 is an isometric view showing a distal end of a
medical device system according to one illustrated embodiment
[0084] FIG. 13 is a cutaway diagram of a heart showing an example
of tissue anchors secured in a mitral valve annulus according to
one illustrated embodiment.
[0085] FIG. 14 is a cutaway diagram of a heart showing an example
of tissue anchors and a cable used to constrict a mitral valve
annulus according to one illustrated embodiment.
[0086] FIGS. 15A and 15B are cross-sectional views of a tool to
secure a cable of an implantable device that constricts a bodily
orifice at two successive intervals of time illustrating a time
prior to cutting the cable and a time when the cable is being cut
according to one illustrated embodiment.
[0087] FIGS. 16A and 16B are sequential isometric views showing a
portion of a catheter with side slots according to one illustrated
embodiment
[0088] FIG. 17 is a cross-sectional partial view of a mechanism
according to one illustrated embodiment for holding a tissue anchor
captive.
[0089] FIGS. 18A and 18B are successive side elevational views of a
mechanism according to one illustrated embodiment for restricting a
tissue anchor from release until the tissue anchor is fully
embedded in tissue.
[0090] FIG. 19A is an isometric view of an implant member according
to one illustrated embodiment, the implant member shown in a
delivery configuration.
[0091] FIG. 19B is a top plan view of the implant member of FIG.
19A shown in the delivery configuration.
[0092] FIG. 19C is an isometric view of the implant member of FIGS.
19A and 19B, the implant member shown in an implantable
configuration.
[0093] FIG. 19D is a front elevational view of the implant member
of FIGS. 19A-19C, shown in the implantable configuration.
[0094] FIG. 20A is an isometric view of an implant member according
to another illustrated embodiment, the implant member shown in a
delivery configuration.
[0095] FIG. 20B is a top plan view of the implant member of FIG.
20A shown in the delivery configuration.
[0096] FIG. 20C is an isometric view of the implant member of FIGS.
20A and 20B, the implant member shown in an implantable
configuration.
[0097] FIG. 20D is a front elevational view of the implant member
of FIGS. 20A-209C, shown in the implantable configuration.
[0098] FIG. 20E is a top plan view showing an implant cross member,
according to one illustrated embodiment.
[0099] FIG. 21A is an isometric view of a fastener that fastens to
a guide line, according to one illustrated embodiment
[0100] FIG. 21B is a cross-sectional view of the fastener and guide
line of FIG. 21A.
[0101] FIG. 22A is an isometric view of a fastener that fastens a
guide line to a tissue anchor, according to another illustrated
embodiment
[0102] FIG. 22B is a cross-sectional view of the fastener, guide
line and tissue anchor of FIG. 22A.
[0103] FIG. 22C is an isometric view of an implant member that has
single piece, unitary part fasteners that fastens a guide line to a
tissue anchor, according to another illustrated embodiment
[0104] FIGS. 23A-23T are sequential schematic diagrams showing an
implant procedure according to one illustrated embodiment, which
includes placement of tissue anchors via an anchor guide frame at
selected locations in an annulus surrounding a mitral valve of a
left atrium of a heart and the securement of an implant member to
the annulus via the tissue anchors.
[0105] FIG. 23U a schematic diagram showing an implant member in
the form of an annuloplasty ring attached to an annulus of a mitral
valve via tissue anchors, guide wires and fasteners, according to
one illustrated embodiment.
[0106] FIG. 24A is an isometric view of an implant member according
to another illustrated embodiment, the implant member shown in a
delivery configuration.
[0107] FIG. 24B is an isometric view of the implant member of FIG.
24A shown mated with a plurality of tissue anchors.
[0108] FIG. 24C shows a plurality of tissue anchors embedded in a
tissue according to an illustrated embodiment.
[0109] FIG. 24D shows an implant member coupled with the embedded
tissue anchors of FIG. 24C.
[0110] FIG. 24E is a sectional exploded view of a portion of the
implant member of FIGS. 24A and 24B prior to a mating with an
embedded tissue anchor.
[0111] FIG. 24F is a sectional view of a portion of the implant
member of FIGS. 24A and 24B mated with an embedded tissue
anchor.
[0112] FIG. 24G is an exploded isometric view of a portion of the
implant member of FIG. 24A and a grapple tissue anchor.
[0113] FIG. 24H is an isometric view of a portion of the implant
member of FIG. 24A mated with a grapple tissue anchor.
DETAILED DESCRIPTION
[0114] In the following description, certain specific details are
set forth in order to provide a thorough understanding of various
embodiments of the invention. However, one skilled in the art will
understand that the invention may be practiced without these
details. In other instances, well-known structures have not been
shown or described in detail to avoid unnecessarily obscuring
descriptions of the embodiments of the invention.
[0115] Reference throughout this specification to "one embodiment"
or "an embodiment" means that a particular feature, structure or
characteristic described in connection with the embodiment is
included in at least one embodiment of the present invention. Thus,
the appearances of the phrases "in one embodiment" or "in an
embodiment" in various places throughout this specification are not
necessarily all referring to the same embodiment. Furthermore, the
particular features, structures, or characteristics may be combined
in any suitable manner in one or more embodiments.
[0116] As used in this specification and the appended claims, the
singular forms "a," "an," and "the" include plural referents unless
the content clearly dictates otherwise. It should also be noted
that the term "or" is generally employed in its sense including
"and/or" unless the content clearly dictates otherwise.
[0117] The headings provided herein are for convenience only and do
not interpret the scope or meaning of the claimed invention.
Overview of Device and Orifice Constriction Methods
[0118] Various embodiments of medical apparatus which are
percutaneously or intravascularly deployed and may be used for
constricting a bodily orifice are described herein.
[0119] FIG. 1 shows a medical device system 100 including an
implantable device 115 and tool 116 to implant the implantable
device 115, according to one illustrated embodiment.
[0120] The tool 116 of the medical device system 100 may be used to
deploy the implantable device 115 having tissue anchors 107 and a
flexible cable 111. The tissue anchors 107 may be secured to the
annulus of an orifice and the flexible cable 111 may be used to
constrict the orifice by pulling the anchors 107 inward. The tool
116 of the medical device system 100 comprises a flexible anchor
guide frame 108 that may be used to guide tissue anchors 107 of the
implantable device to target positions on the orifice annulus. The
anchor guide frame 108 may be made of a material such as Nitinol.
The anchor guide frame 108 shown in FIG. 1 is comprised of three
guide members, for instance guide wires 112,--one guide member for
each of the tissue anchors 107 shown. The guide frame 108 may
include a different number of guide members or arms (e.g., guide
wires or guide rails) if more tissue anchors are desired. The guide
members 112 shown preferably have hinges 113 and may be connected
with small loops 109. The hinges 113 and loops 109 enable the guide
frame 108 to fold up to fit inside a catheter and to expand to
extend across an orifice. Both the hinges 113 and loops 109 may be
replaced by other mechanisms or structures that enable bending or
compression. The tool 116 of the medical device system 100
typically has an articulation mechanism 106 (e.g., a plurality of
articulation joints) that enables correctly orienting the anchor
guide frame 108 during deployment of tissue anchors 107. The
articulation mechanism 106 is preferably able to bend in any
direction. The tool 116 of the medical device system 100 may
include control knobs 103 and 104 which may be used to control the
bending of the articulation mechanism 106 via cables that are
carried in long flexible tube 105.
[0121] Long flexible tube 105 extends from the articulation
mechanism 106 to a medical device control mechanism 114 located at
a proximal end of the catheter. Control mechanism 114 may include
control knobs 103 and 104, elongated release members (e.g., rods or
wires) 101, push tubes 102, and guide wires 112. Additional
controls may be included in other embodiments. The flexible tube
105 may have multiple lumens. Multi-lumen push tubes 102, guide
members (e.g., guide wires) 112, release members 101, cable 111,
and other mechanisms may be carried in flexible tube 105. In the
illustrated embodiment, each push tube 102 has two lumens. A guide
wire 112 is carried in a first lumen and a release member 101 is
carried in a second lumen. Anchors 107 are attached at distal tips
of release members 101. The tissue anchor 107 may be inserted into
the annulus of an orifice by advancing the push tube 102 along the
guide member 112 and advancing or rotating the release member 101
carried in the push tube 102 at the same rate. The tissue anchor
107 may advance past the hinge 113 and embed into the annulus of
the orifice to be constricted while in an unretracted
configuration. Once the tissue anchor 107 is embedded, the release
member 101 attached to the anchor may be retracted while the push
tube 102 is held in place in a retracted configuration. Retraction
of the release member 101 causes the tissue anchor 107 to detach
from the distal tip of the release member 101 and remain embedded
in the tissue at least proximate a desired location. Other
embodiments may use different methods and/or structures to release
the tissue anchors 107.
[0122] FIG. 2 shows an implantable device 207, 210 implanted in a
portion of a heart to constrict a bodily orifice, for example a
mitral valve of the heart, according to one illustrated
embodiment.
[0123] A portion of the medical device system 100 may be
percutaneously and/or intravascularly inserted into a portion of a
heart 212, for example in a left atrium 206 of the heart 212. In
this example embodiment, a flexible anchor guide frame 214 and
implantable device are delivered via a catheter 202 inserted via
the inferior vena cava 204 and penetrating the transatrial septum
213 from a right atrium 203. The catheter 202 is preferably less
than 8 mm in diameter.
[0124] The flexible anchor guide frame 214 expands after being
delivered via the catheter 202 into a shape that preferably enables
the tissue anchors 207 of the implantable device to be delivered to
the desired respective positions on the mitral annulus 209. The
flexible anchor guide frame 214 may be moved into the correct
orientation by adjusting a shape of an articulation mechanism 205,
advancing or retracting flexible tube 201, or rotating flexible
tube 201. The flexible anchor guide frame 214 preferably has an
overall shape that enables the frame to take on a desired
orientation within a cavity by conforming to the shape or being
affected by the movement of anatomical features. Such a property is
known as "self-locating". Minimal insertion force and operator
guidance is typically needed to properly position the anchor guide
mechanism. The flexible anchor guide frame 214 may also have
specific features which cause the flexible anchor guide frame 214
to orient correctly based on the position of an anatomical feature,
such as the mitral valve cusps or leaflets 211. An example of such
a feature is alignment fin 215. Alignment fin 215 is attached
rigidly to flexible anchor guide frame 214 and shaped so that it
may be deflected to a particular orientation by an anatomical
feature, such as mitral valve leaflets 211. As the flexible anchor
guide frame 214 is advanced toward an anatomical feature, such as
the mitral valve annulus 209, the shape or motion of an anatomical
feature, such as the mitral valve leaflets 211, may cause alignment
fin 215, and thus attached flexible anchor guide frame 214, to
rotate or translate to a desired orientation or location.
[0125] The tissue anchors 207 may be inserted into the annulus 209
by advancing the push tubes 216 along the guide members (e.g.,
guide wires or rails) 112. The tissue anchors 207 may advance past
the bend 208 and embed into the annulus 209. The embedded tissue
anchors 207 may then be released from the push tubes 216. The
flexible cable 210 connecting the tissue anchors 207 may then be
tightened and secured to constrict the mitral annulus 209.
[0126] FIG. 3 shows an example of a tissue anchor according to one
illustrated embodiment.
[0127] The tissue anchor 301 has a helical structure with sharp tip
303, and hence is denominated as a helical tissue anchor 301. Loop
302 may be used to connect to a structure to hold the tissue anchor
301 to a release rod. Loop 302 may also be used to attach tissue
anchor 301 to a cable used for cinching the annulus of a bodily
orifice.
[0128] FIGS. 4A and 4B show an example of a tissue anchor according
to one illustrated embodiment.
[0129] In particular, FIG. 4A shows the tissue anchor 403 in a
compressed configuration, while FIG. 4B shows the tissue anchor 406
in an expanded configuration. The tissue anchors 403, 406 comprise
multiple barbs 408 (not shown in FIG. 4A), which may be resilient.
The multiple barbs 408 may be compressed into constriction tube 404
as shown for tissue anchor 403. Compression of barbs 408 into
constriction tube 404 enables the anchor to move more readily
through a catheter and also to be inserted more readily into tissue
without causing damage to the tissue.
[0130] Tissue anchor 403 may include a hole 409 that may be used to
attach the anchor to a cable 401 used for cinching the annulus of a
bodily orifice. Constriction tube 404 may include a slot 402 to
allow anchor 403 to be ejected from constriction tube 404 in the
case where hole 409 is mounted on a protruding flange.
[0131] Tissue anchor 406 may include a hole 407 that may be used to
connect said anchor to release rod 405. Release rod 405 may be
carried in a lumen of push tube 410. If constriction tube 404 is
extended over hole 407 as shown for anchor 403, release rod 405 is
held captive in hole 407 by the wall of tube 404. If constriction
tube 404 is retracted so as to not cover hole 407, as shown for
tissue anchor 406, release rod 405 is not held captive in hole 407
and said tissue anchor may become disconnected from constriction
tube 404 and release rod 405.
[0132] Tissue anchor 406 may be disconnected from release rod 405
and barbs 408 may be uncompressed by retracting constriction tube
404 relative to the release rod 405 and tissue anchor 406.
Retracting constriction tube 404 past the tips of barbs 408 causes
said barbs to be released and resiliently expand. Retracting
constriction tube 404 past hole 407 may release tissue anchor
406.
[0133] FIGS. 5A-5E show examples of five types of tissue anchors
embedded in tissue.
[0134] In particular, FIG. 5A shows a helical anchor 501 embedded
in tissue 502. The helical tissue anchor 501 is embedded in tissue
502 by rotating the helical tissue anchor 501 about is longitudinal
axis. FIG. 5B shows a multi-barbed anchor 505 embedded in tissue
502. The multi-barbed tissue anchor 505 is embedded in tissue 502
by pushing the anchor into the tissue. Barbs 504 provide resistance
to restrict the tissue anchor 505 from being extracted. FIG. 5C
shows a tissue anchor 510 with multiple barbs 512 (only one called
out in FIG. 5C) and an integral guide line or guide wire 514
embedded in tissue 502. The barbs 512 and guide line 514 may be
secured in a shell 516 of the tissue anchor 510. For example, the
barbs 512 and guide line or guide wire 514 may be secured via
swaging. The guide line 514 may take a variety of forms, for
example a metal wire such as Nitinol. FIG. 5D shows a tissue anchor
520 with multiple barbs 522 (only one called out in FIG. 5D) and a
unitary guide line or guide wire 524 embedded in tissue 502. In
contrast to the embodiment of FIG. 5C, the embodiment of FIG. 5D
forms the tissue anchor 520 and guide line or guide wire 524 from a
single piece of material, for instance a thin flexible metal wire,
which is selected from metals that are biocompatible (e.g.,
stainless steel, Nitinol).
[0135] FIG. 5E shows a grapple tissue anchor 530 implanted into
tissue 502. Grapple tissue anchor 530 includes a plurality of
elongated members 535. At least two of the elongated members (i.e.,
first elongated member 535a and second elongated member 535b in
this example embodiment) are pivotably coupled together by pivot
member 539. Each of the elongated members 535 includes a first end
536, a second end 537, an intermediate portion 538 and a respective
length along the elongated member 535 extending between the first
end 536 and the second end 537. Each second end 537 includes a tip
540 shaped to penetrate tissue 502. In some example embodiments,
each second end 537 includes a barb. In this example embodiment,
each of the elongated members 535 is an arcuate elongated member.
In this example embodiment, each of the elongated members 535 forms
a prong. Pivot member 539 allows the elongated members 535 to pivot
with respect to one another to space tips 540 apart from one
another into a configuration advantageous for penetrating tissue
502. Upon further deployment of grapple tissue anchor 530 into
tissue 502, the elongated members 535 are pivoted to draw tips 540
towards each other which causes tips 540 to travel along a path
through tissue 502 such that tips 540 are positioned closer to one
another than during their initial deployment into tissue 502. This
allows grapple tissue anchor 530 to firmly anchor itself into
tissue 502. In this example embodiment, the plurality of elongated
members 530 is physically coupled to a plurality of flexible lines
542a and 542b (collectively 542). Specifically, flexible line 542a
is coupled to elongated member 535a and flexible line 542b is
physically coupled to elongated member 535b. In this example
embodiment, elongated member 535a includes an opening 544a sized to
receive flexible line 542a and elongated member 535b includes an
opening 544b sized to receive flexible line 542b. In some example
embodiments, a single flexible line 542 is received in an opening
provided in each of the elongate members 535. In this example
embodiment, the flexible lines 542 are guide lines. In some example
embodiments, the flexible lines 542 and respective ones of the
elongate members 535 are provided as a unitary structure.
[0136] FIGS. 6A and 6B show examples of tissue anchors guided by a
guide member in the form of a guide rail.
[0137] In particular, FIG. 6A shows a multi-lumen push tube 600
that may slide over a guide rail 601. Tissue anchor 602 may be
temporarily attached to multi-lumen push tube 600 by constriction
tube 606 and a release rod (not shown). Sliding push tube 600 along
guide rail 601 enables tissue anchor 602 to be controllably
delivered to a location proximate to guide rail 601. Tissue anchor
602 may be constructed or oriented in such a way that tissue anchor
tip 607 slides along or very near to guide rail 601. Such
orientation or construction enables the tip to be protected from
obstructions in the catheter or body that may dull the tip. Also,
such orientation or construction protects areas of tissue proximate
the guide rail from inadvertent, damaging contact with the sharp
tip 607 of tissue anchor 602.
[0138] FIG. 6B shows a single-lumen push tube 603 that may slide
over guide rail 601. Helical tissue anchor 604 also may slide over
guide rail 601 and may be temporarily attached to single-lumen push
tube 603 by latch mechanism 609. Latch mechanism 609 may be
fastened to tissue anchor 604 by a friction fitting that is
released under sufficient axial force. This assembly enables tissue
anchor 604 to be controllably delivered to a location proximate to
guide rail 601. Tissue anchor 604 may be constructed or oriented in
such a way that tissue anchor tip 608 slides along or very near to
guide rail 601. Such orientation or construction enables the tip of
the tissue anchor 604 to be protected from obstructions in the
catheter or body that may dull the tip. Also, such orientation or
construction protects areas of tissue proximate the guide rail 601
from inadvertent, damaging contact with the sharp tip of tissue
anchor 608.
[0139] While FIGS. 6A and 6B show examples of two particular types
of tissue anchors being guided by a rail, it will be apparent to
those skilled in the art that many other types of tissue anchors
could also be deployed with the aid of a guide rail as well.
[0140] FIGS. 7A-7C illustrates deployment of helical tissue anchors
implanted or embedded in tissue according to one illustrated
embodiment.
[0141] In particular, FIG. 7A shows a helical tissue anchor 702
partially deployed into tissue 708. The location that tissue anchor
702 enters the tissue may be determined by the position of a guide
member, for instance guide rail 704. Bend 707 in guide rail 704 may
be positioned at the approximate location where the tissue anchor
702 is to be deployed into the tissue. Bend 707 in guide rail 704
may comprise a hinge, a flexure, or one of many other joints.
Tissue anchor 702 is deployed by rotating push tube 703. The
rotation of tissue anchor 702 at the position of the bend 707
causes tissue anchor 702 to spiral off guide rail 704 and into
tissue 708.
[0142] FIG. 7B shows a helical tissue anchor 705 fully deployed
into tissue 708, but still connected to latch mechanism 709. In the
fully deployed position, helical tissue anchor 705 may no longer
wrap around guide rail 704. When still connected to latch mechanism
709, the helical tissue anchor 705 may be readily retracted by
counter-rotating push tube 703.
[0143] FIG. 7C shows a helical tissue anchor 706 fully deployed
into tissue 708 and disconnected from to latch mechanism 709. Latch
mechanism 709 may become disconnected from tissue anchor 706 by
retracting push tube 703 or releasing latch mechanism 709 with the
addition of another cable to trigger a release mechanism.
[0144] FIGS. 8A and 8B show deployment of multi-barbed tissue
anchors in tissue according to one illustrated embodiment.
[0145] In particular, FIG. 8A shows a multi-barbed tissue anchor
805 fully inserted into tissue 804, but still encapsulated or
retained by constriction tube 809. The location that the
multi-barbed tissue anchor 805 enters the tissue may be determined
by the position of a guide member, for instance guide rail 803. A
bend 810 in guide rail 803 may be positioned at the approximate
location where the multi-barbed tissue anchor 805 is to be deployed
into the tissue 804. The bend 810 in guide rail 803 may be
constructed using a hinge, a flexure, or one of many other methods.
The multi-barbed tissue anchor 805 is deployed by advancing push
tube 802 over guide rail 803. If encapsulated or retained by
constriction tube 809, multi-barbed tissue anchor 805 may be
readily retracted by retracting push tube 802.
[0146] FIG. 8B shows a multi-barbed tissue anchor 808 fully
inserted into tissue 804, but disconnected from constriction tube
811 and release member 806. The multi-barbed tissue anchor 808 is
preferably retracted slightly before release member 806 is
disconnected in order to cause barbs 807 to expand. The
multi-barbed tissue anchor 808 may be disconnected from release
member 806 and barbs 807 may be expanded by retracting constriction
tube 809 relative to the release member 806 and multi-barbed tissue
anchor 808. Retracting constriction tube 811 past the tips of barbs
807 causes the resilient barbs to be released and expand.
[0147] FIGS. 8C through 8F show a tissue anchor 820 movably guided
to tissue 824 and penetrating the tissue 824 at four successive
intervals of time, according to one illustrated embodiment.
[0148] In particular, FIG. 8C shows a guide member portion of an
anchor guide frame 826 of a tool initially contacting the tissue
824.
[0149] The guide member portion of the anchor guide frame 826
includes an outer tube 828 having two lumens 830a, 830b. The guide
member portion includes an engagement or locating member 832. The
engagement or locating member 832 is used to physically engage the
tissue 824 such that the anchor guide frame 826 is at a desired
location and orientation in a bodily organ. The engagement or
locating member 832 is movingly carried in one lumen 830a of the
outer tube 828. The anchor guide frame 826 includes an inner or
guide tube 834 movingly received in the other lumen 830b of the
outer tube 828. The guide tube 834 functions to guide the tissue
anchor 820 to a desired location on the tissue 824. A lumen 836 of
the guide tube 834 carries a guide wire 838. The guide wire 838 is
a thin flexible wire, for example a thin Nitinol wire. The guide
wire 838 may include a lubricous coating or layer, such as
polytetrafluoroethylene. The guide tube 834 provides lateral
support for the guide wire 838 and retains barbs 840 if the tissue
anchor 820 is in a protected, contracted configuration. A butt end
of the guide tube 834 may physically engage or bear against an end
or lip of the tissue anchor 820. Thus, when the guide tube 834 and
guide wire are pushed, the motion is effectively delivered to the
tissue anchor 820, which will advance out of the outer tube 828
along with the inner or guide tube 834. The guide tube 834 may
optionally be reinforced with one or more wires, for instance
Nitinol wires. The guide wire 838 is attached to the tissue anchor
820 and functions as a guide line for an implant member (not shown
in FIGS. 8C-F), as described in detail further below.
[0150] In particular, FIG. 8D shows the tissue anchor 820 being
embedded in the tissue 824, along with a portion of the guide tube
834 and guide wire 838. FIG. 8E shows the guide tube 834 partially
withdrawn from around the tissue anchor 820, exposing the barbs 840
of the tissue anchor 820. In going from FIG. 8D to FIG. 8E, the
guide wire 838 is pushed relatively toward the tissue 824 while the
guide tube 834 is pulled or drawn away from the tissue 824. Pushing
the guide wire 838 supplies enough force to retain the tissue
anchor 820 in the tissue 824 against any force exerted by way of
withdrawal of the guide tube 834. As the guide tube 834 clears the
barbs 840, the barbs 840 expand due to the resiliency of the
material from which the barbs 840 are fashioned. The tissue anchor
820 is thus secured within the tissue 824.
[0151] FIG. 8F shows the tissue anchor 820 and guide wire 838 which
remain after the portion of the anchor guide frame 826 is
withdrawn. The guide tube 834 may be fully retracted into the lumen
830b of the outer tube or catheter 828 prior to withdrawal of the
anchor guide frame 826 from the bodily organ. As explained in
detail below, the guide wire 838 may be used to guide an implant
member (e.g., annuloplasty ring) to the tissue 824, and/or to
secure the implant member to the tissue 824 at a desired position
and orientation.
[0152] While illustrated with two tubes per anchoring location,
some embodiments may employ three tubes per anchoring location or
more. Using only two tubes per anchoring location advantageously
increases the flexibility of the catheter(s) relative to
embodiments employing more than two tubes per anchor location. Such
eases the movement of the catheter through the bodily lumen (e.g.,
artery). Such may also allow the use of catheters with smaller
diameters than would otherwise be necessary to accommodate one or
more additional tubes per anchoring location.
[0153] FIG. 9 shows an example of an anchor guide frame of a tool
according to one illustrated embodiment.
[0154] An anchor guide frame 901 is used to guide tissue anchors of
the implant device to correct insertion or anchor points or
locations. The anchor guide frame 901 shown comprises three guide
members, for instance rails 905, but said guide frame may comprise
more or fewer guide members. The anchor guide frame 901 embodiment
illustrated shows all guide rails 905 connected at the bottom of
the guide frame 901. An anchor guide frame is not required to have
all guide members connected together, although it is often
preferable to do so to create a guide frame that enables tissue
anchors to be positioned relative to each other and to anatomical
features. Thus, an anchor guide frame may have multiple
disconnected groups of connected guide wires.
[0155] The anchor guide frame 901 preferably is capable of folding
to enable delivery via a catheter. Guide members (e.g., guide wires
or rails) 905 may be hinged at bends 902 and guide connection point
904 to enable folding. Loop 903 facilitates folding and also acts
as a spring to enable unfolding of the anchor guide frame 901.
[0156] Guide members 905 may be formed to have respective bends 906
when no external forces are being applied. When guide members 905
are carried in a catheter with an articulation mechanism shaped
into a curve as shown in FIG. 2, the forces exerted on the guide
member by the catheter and articulation mechanism will cause bend
906 to align with the curve in the articulation mechanism. Such
alignment causes anchor guide frame 901 to rotate to a desired
position relative to the catheter orientation. Bend 906 may also be
formed to assist in curving the articulation mechanism in a
particular way.
[0157] An anchor guide frame may also contain additional features
which use anatomical features or movement to assist in orientation
of said anchor guide mechanism or guide frame 901. An example of
such a feature is an alignment fin 907. Alignment fin 907 is
attached rigidly to flexible anchor guide frame 901 and shaped so
that the alignment fin 907 may be deflected by an anatomical
feature, such as mitral valve leaflets, to a particular
orientation. As the flexible anchor guide frame 901 is advanced
toward an anatomical feature, such as the mitral valve annulus, the
shape or motion of an anatomical feature, such as the mitral valve
leaflets, may cause alignment fin 907, and thus flexible anchor
guide frame 901, to rotate to a desired orientation.
[0158] FIG. 10 shows an anchor guide frame folded for delivery
inside a catheter according to one illustrated embodiment.
[0159] An anchor guide frame including guide members (e.g., guide
wires or rails) 1004 may be folded inside a catheter sheath 1001.
Hinges 1006 and loop 1007 enhance folding of the anchor guide
mechanism. In the embodiment illustrated, tissue anchors 1003 fit
between the guide members 1004 in the folded configuration.
Protective anchor cap 1005 holds and covers the sharp tips of
tissue anchors 1003 and may ensure that the tips do not catch or
embed on the sides of catheter sheath 1001. Protective anchor cap
1005 may be held in place by control wire 1002
[0160] FIG. 11 shows an anchor guide frame in an expanded
configuration according to one illustrated embodiment.
[0161] An anchor guide frame 1112 may self expand after exiting
catheter sheath 1111. In particular, the anchor guide frame 1112
may be formed of a resilient material or a shape memory material
such as Nitinol. Loop 1106 may be formed to cause the anchor guide
frame 1112 to expand. Hinges 1105 facilitate separation of guide
members 1104 by about 20 mm to 45 mm. In the illustrated
embodiment, tissue anchors 1109 are held within the volume
encompassed by anchor guide frame 1112 which ensures the tissue
anchors 1109 do not accidentally impinge tissue. Also, the tips of
the tissue anchors are held captive within protective anchor cap
1110. The tips of the tissue anchors may be released by advancing
control wire 1103 and thereby also advancing anchor cap 1110. The
tips of the tissue anchors are no longer held captive if anchor cap
1110 is advanced sufficiently to a point past the tips of the
tissue anchors. As guide members 1104 curve away from anchor cap
1110, advancing tissue anchors 1109 causes the tips of the tissue
anchors to move away from and avoid anchor cap 1110.
[0162] Articulation mechanism 1107 (e.g., articulation joints) of
the tool is shown in a curved configuration or state. Articulation
mechanism 1107 may be curved using wires (not shown) that are
carried on opposing sides relative to a longitudinal axis of the
articulation mechanism and fixed to the distal end of the
articulation mechanism 1107. Tensioning one wire causes the
articulation mechanism 1107 to arc in the direction of the side of
the articulation mechanism on which the tensioned wire is carried
in. For some situations, it is desirable to cause gaps between
articulation links or articulation joints to open at different
rates. For example, when inserting articulation mechanism 1107 into
the left atrium, it may be preferable to cause the distal links,
such as articulation link or joint 1113 and articulation link or
joint 1114, to separate or bend prior to or more than the proximal
articulation links or joints, such as articulation link or joint
1115 and articulation link or joint 1116. One embodiment to enable
such an attribute is to insert springs, as indicated by 1108 and
1102, with varying spring constant k between the links or
articulation joints. To cause the distal end of articulation
mechanism 1107 to bend first, the distal links should be forced
apart by springs with a higher spring constant than the springs
between the proximal links. Another embodiment for enabling unequal
separation of articulation links or joints is to control the shape
of the guide members 1104 that are routed through the articulation
mechanism 1107. The guide members should have a preformed bend with
a decreasing radius of curvature in the area from proximal
articulation link or joint 1115 to distal articulation link or
joint 1114.
[0163] FIG. 12 shows a configuration of tissue anchors and push
tubes at a distal tip of a medical device system according to one
illustrated embodiment. For clarity, FIG. 12 omits guide members
and anchor guide frame that would typically be located at the
distal tip of the medical device system.
[0164] An articulation mechanism 1204 may include multiple lumens
1208 through which push tubes 1202 are carried. In this particular
embodiment, three lumens 1208 are employed, but other embodiments
may comprise more or less. Push tubes 1202 may also include
multiple lumens. In this particular embodiment, each push tube 1202
has a lumen 1201 in which a guide member (e.g., guide wire or rail)
(not shown) may be carried and a second lumen that carries a
release member (e.g., rod or wire) (not shown) which is connected
to the tissue anchors 1209. Constriction tubes 1205 may be mated
into or onto the distal end of the second lumen. All tissue anchors
may be connected by a flexible cable 1207. The flexible cable 1207
may also be carried within a separate lumen within the articulation
mechanism 1204. Lumens 1203 are used to carry cables that control
the curvature of the articulation mechanism 1204.
[0165] FIG. 13 shows a cross section of a heart with an anchor
guide frame according to one illustrated embodiment positioned
within a left atrium of the heart.
[0166] An anchor guide frame 1303 is shown self-located on a mitral
annulus 1304 within the left atrium. The tissue anchor deployment
sites 1301 are preferably located on the mitral annulus and
coincident with bends in the guide members (e.g., guide wires or
rails) 1302. While FIG. 13 shows three guide members 1302 and
tissue deployment sites 1301 for simplicity; in many cases more
deployment sites and guide members are desirable. In such cases, it
is a simple matter to add additional guide members and anchor
deployment sites to the illustrated embodiment.
[0167] An alignment fin 1305 may fit between mitral valve leaflets
1306. The movement and anatomical structure of the mitral valve
leaflets 1306 exert force on alignment fin 1305 and assist in
orienting the anchor guide frame 1303 correctly
[0168] FIG. 14 shows a cross section of a heart with an installed
assembly capable of constricting a mitral valve annulus according
to one illustrated embodiment.
[0169] Tissue anchors 1401, 1402, and 1403 are shown fully deployed
on the mitral annulus 1406. Tissue anchors 1401-1403 may be
connected by a flexible cable 1405. Other mechanisms for connecting
tissue anchors 1401, 1402, 1403 are possible. For example, rigid
members, preferably with adjustable length (e.g., turn-buckles),
may be used to connect the tissue anchors 1401-1403. Flexible cable
1405 may slide through holes on the tissue anchors 1401, 1402,
1403.
[0170] Flexible cable 1405 may pass through a hollow spreader bar
1404. Hollow spreader bar 1404 provides support to keep tissue
anchors 1401 and 1403 from moving closer together when flexible
cable 1405 is shortened. Such support reduces undesired forces
being applied to an aortic valve 1407 of the heart.
[0171] Reducing a distance between pairs of the tissue anchors
1401, 1402 and 1402, 1403 causes an anterior-posterior (A-P)
annular dimension of the mitral valve to reduce and improves
leaflet coaptation. Several methods may be used to reduce the
distance between two or more pairs of tissue anchors 1401, 1402 and
1402, 1403. A first method is to shorten the cable during the
installation procedure by routing the flexible cable 1405 through
fastener 1408, pulling the cable manually to be as tight as desired
and crimping fastener 1408. Fastener 1408 may also be constructed
using a one way clutch so that the flexible cable 1405 can only be
pulled through in one direction, in which case crimping is not
required. A second method of reducing tissue anchor separation
(i.e., distance between two successive tissue anchors) is to
include shortening actuator 1409 between two tissue anchors. In the
case where shortening actuator 1409 is included, flexible cable
1405 is split and attached to either end of the shortening
actuator. One embodiment of shortening actuator 1409 contains an
element that is capable of changing length as a response to a
stimulus such as changes in an external magnetic field or heating
induced by a changing magnetic field. The element capable of
changing lengths may be made of a highly magnetostrictive alloy
such as Terfenol-D or from a Shape Memory Alloy (SMA) such as
specially treated Nitinol. Embodiments of such actuators are
described in U.S. Ser. No. 11/902,199. The element capable of
changing lengths may be made of a spring under tension (e.g., in an
extended configuration) encapsulated in a retainer material that
changes state in response to a stimulus (e.g., melts under low heat
and solidifies at body temperature--such as a thermoplastic
polymer). Current induced in a loop by an external magnetic field
may be channeled through the spring. The current may heat the
spring which will cause the polymer to soften and the spring length
to contract to an unextended configuration. The contraction of the
spring can be used to reduce the separation of the tissue anchors.
Embodiments of such actuators are described in U.S. Ser. No.
11/905,771.
[0172] A closed, electrically conducting loop is required if
shortening actuator 1409 is to be responsive to heating or energy
induced by a changing magnetic field. Such a loop may be achieved
by using an electrically conductive material for flexible cable
1405 and ensuring an electrical contact between both ends of
flexible cable 1405 that are connected to shortening actuator
1409.
[0173] FIGS. 15A and 15B show a tool and fastener used to tighten
and secure a cable according to one illustrated embodiment.
[0174] Fastener 1507 may be used to tighten or secure cables being
used to constrict a bodily orifice. Typically prior to attachment
of fastener 1507, tissue anchors have been implanted or placed in
the tissue, and a flexible cable has been connected to the tissue
anchors. Cable end 1504 and cable end 1503 are typically carried in
catheter sheath 1505 and routed outside the body. Cable end 1504
and cable end 1503 may be the two ends of one flexible cable. The
portion of the cable not shown loops around the orifice to be
constricted and is attached to the implanted tissue anchors used to
secure the cable to the orifice.
[0175] Cable end 1504 may be fed into hole 1511 and locked by
ferrule 1510 while fastener 1507 is still outside the body. Cable
end 1503 may be routed through taper lock 1509 while fastener 1507
is still outside the body.
[0176] Fastener 1507 may be attached to fastener positioning tube
1506. Cable end 1503 may be inserted through slot 1502 and into
fastener positioning tube 1506. Fastener 1507 and fastener
positioning tube 1506 may be inserted into catheter sheath 1505 and
advanced until fastener 1507 is proximate an annulus of the orifice
to be constricted. Cable end 1503 may be pulled in a direction away
from fastener 1507, causing the cable to pull through taper lock
1509 and constrict the orifice. While the cable is being tightened
and secured, fastener 1507 may be held by fastener positioning tube
1506. Taper lock 1509 restricts cable end 1503 from being pulled
out the right side (as illustrated in FIGS. 15A, 15B) of fastener
1507. Taper lock 1509 may have teeth 1515 to grip cable end 1503.
Taper lock 1509 may have a longitudinal slot to enable compression
of taper lock 1509 and constriction around cable end 1503. Spring
1508 may force taper lock 1509 into a conical hole 1514, causing
the force taper lock 1509 to tighten around cable end 1503.
[0177] When the orifice has been sufficiently constricted, cable
end 1503 may be severed using cable cutting tube 1501. Cable
cutting tube 1501 includes a sharpened end 1516. In particular,
FIG. 15A shows cable cutting tube 1501 in a retracted position. The
cable cutting tube may slide inside of fastener positioning tube
1506. FIG. 15B shows cable cutting tube 1512 in the cable cutting
position, physically engaging the cable 1513. Cable cutting tube
1512 may sever cable end 1513 by forcing cable end 1513 against the
end of slot 1516. The cable end may be severed in other ways,
including using a hot tip to melt through the cable.
[0178] FIGS. 16A and 16B show a catheter with grooves, or side
slots, and a mechanism for securing cables or wires in said side
slots according to one illustrated embodiment.
[0179] In particular, FIG. 16A shows catheter 1604 with cables 1601
held within longitudinal groove 1603 on the inner surface of the
tube wall by tube 1602. The longitudinal groove 1603 has a cross
sectional shape that enables tube 1602 to be held captive. FIG. 16A
shows a circular groove (i.e., arcuate cross-section), but other
shapes may be used. Tube 1602 carries cables 1601. Tube 1602 could
also carry wires or tubes. When tube 1602 is removed by pulling it
out the end, as shown in FIG. 16B by catheter 1607, cables 1605 are
free to move into the central area of the tube. Tube 1602 can be
reinserted over cables 1605 to again constrain them in groove
1603.
[0180] Although FIGS. 16A and 16B show catheter 1604 and catheter
1607 with only one groove 1603, it is possible to have many such
grooves in a catheter and to secure a plurality of wires and tubes
in said grooves. One of the reasons for securing cables or wires in
grooves, or side slots, is to eliminate tangling of cables or wires
during medical procedures.
[0181] FIG. 17 shows a mechanism for holding a tissue anchor
captive according to one illustrated embodiment
[0182] Tissue anchor 1703 may be held captive in constriction tube
1706 of the tool by release member 1704. Constriction tube 1706 may
be inserted and secured to a distal end of one lumen of push tube
1701. Constriction tube 1706 may be held captive in the lumen by
one or more ribs 1705.
[0183] Tissue anchor 1703 may be released from constriction tube
1706 by retracting push tube 1701 and constriction tube 1706
relative to release member 1704. As the distal end of constriction
tube 1706 clears hole 1707, tip of release member 1708 will pop out
of hole 1707 and tissue anchor 1703 will no longer be held
captive.
[0184] Lumen 1702 of push tube 1701 may be used to slide over a
guide member.
[0185] FIGS. 18A and 18B show mechanisms for restricting a tissue
anchor from release until anchor is fully embedded in tissue
according to one illustrated embodiment
[0186] An additional benefit is provided if the tool to implant the
implantable device for constricting a bodily orifice does not
release tissue anchors of the implantable device until the tissue
anchors are fully embedded in the tissue. It is possible to achieve
this benefit by adding an additional latch 1806, 1810 to the
tool.
[0187] In particular, FIG. 18A shows a tissue anchor 1802 prior to
deployment. The tissue anchor 1802 may not be released from
constriction tube 1805 by retracting push tube 1803 and
constriction tube 1805 relative to release member 1804 because
latch 1806 in an engaged or locked position extends into a notch
1801. Latch 1806 is coupled to lever 1807 in this illustrated
embodiment.
[0188] FIG. 18B shows the tissue anchor 1808 fully deployed into
tissue 1812. As tissue anchor 1808 was deployed into tissue 1812,
the surface of tissue 1812 causes lever 1811 to bend. When lever
1811 is bent, latch 1810 clears notch 1813. Once latch 1810 clears
notch 1813, tissue anchor 1808 may be released from constriction
tube 1809.
[0189] FIGS. 19A-19D show an implant member 1900, according to one
illustrated embodiment. In particular, FIGS. 19A and 19B show the
implant member in a first configuration that is representative of
one of a delivery configuration, an unanchored configuration or an
untensioned configuration, while FIGS. 19C and 19D show the implant
member in second configuration that is representative of one of an
implantable configuration, a deployed configuration, an anchored
configuration or a tensioned configuration. This implant member
1900 may be particularly suitable for use with the tissue anchors,
anchoring guiding frame and techniques of FIGS. 5C, 5D, and FIGS.
8C-8F.
[0190] The implant member 1900 may be used to reshape, reconfigure
and/or reinforce an orifice in bodily tissue. For example, the
implant member 1900 may be used to reshape, reconfigure and/or
reinforce a valve, for instance a natural valve or an artificial
valve. The valve may, for example take the form of a mitral,
tricuspid, pulmonary and/or aortic valve of the heart.
Alternatively, the valve may take the form of another valve in
another organ of the body.
[0191] The implant member 1900 has a plurality of arcuate segments
1902a-1902c (collectively 1902). While three segments 1902 are
illustrated, the implant member 1900 may include additional
segments. The total number of segments 1902 may be based on the
size of the valve that the implant member 1900 will be used with.
The total number of segments 1902 may additionally or alternatively
be based on a largest lateral dimension that may be accommodated by
a given or desired catheter (i.e., diameter of catheter lumen). For
instance, employing a greater number of segments 1902 means that
each segment may have a smaller height 1922, while still achieving
a desired lateral dimension or height of the overall implant member
1900 when in the implanted configuration.
[0192] The segments 1902 are physically coupled to one another, and
in at least some configurations are articulated for movement with
respect to one another, for example pivotal movement. The implant
member 1900 includes a number of hinges 1904a, 1904b (collectively
1904 pivotally coupling neighboring ones of the segments 1902. Each
hinge 1904 may include a hinge pin 1906a, 1906b (collectively 1906)
received via throughholes 1908a, 1908b (collectively 1908) in the
segments 1902. The hinge pin 1906 should be fixedly received in the
throughhole 1908 to ensure that the hinge pin 1906 does not become
dislodged after implantation. The hinge pin 1906 may be swaged in
the throughhole 1908, and may additionally or alternatively be
fixed using other mechanisms. The locations of the hinge pins 1906
of the hinges 1904 may be offset from a longitudinal centerline
(i.e., the arc that passes longitudinally through the geometric
center between the longitudinal arcuate edges) of the respective
one of the arcuate segments 1902. Such may avoid having to remove
material on an outside edge to allow the segments 1902 to pivot.
Alternatively, the hinge pins 1906 may lie along the longitudinal
centerline.
[0193] The segments 1902 include stops 1909a-1909d (collectively
1909) proximate the hinges 1904. The stops 1909 on neighboring ones
of the segments 1902 cooperatively interact by engaging one another
to prevent the segments 1902 from being pivoted past a defined
angle with respect to one another. The stops thus serve to lock the
segments 1902 from further articulation in one direction, from the
delivery configuration to the implanted configuration. While
illustrated as simple complimentary engagement surfaces, the stops
may take other forms. For example, stops may take the form a detent
or other lock structure. Stops 1909 may lock the segments 1902 from
movement in two, opposed directions. Stops 1909 may also provide
torsional stiffness to the hinges 1904.
[0194] In some example embodiments, a portion of an implant member
having a variable bending stiffness in at least one dimensional
plane is employed. In this illustrated embodiment, implant member
1900 is configured to be bendable between a first configuration in
which implant member 1900 has an elongated shape and a second
configuration in which implant member 1900 has an arcuate shape.
Stops 1909 allow portions of the implant member 1900 coupled by
hinges 1904 to have a variable bending stiffness in at least one
dimensional plane. Hinges 1904 allow implant member 1900 to bend
via the articulation of segments 1902 in a plane when implant
member 1900 is in its first configuration. Stops 1909 restrain
further articulation between segments 1902 when implant member 1900
is in the second configuration and any further bending is dependent
on any additional flexing of segments 1902. In this regard, the
implant member 1900 has a reduced bending stiffness in the at least
one dimensional plane when the implant member 1900 is in the first
configuration and an increased bending stiffness in the one
dimensional plane when the implant member 1900 is in the second
configuration. Variable bending stiffness characteristics can be
achieved in other ways by other example embodiments. The implant
member 1900 includes a number of guide line receivers 1910a-1910c
(collectively 1910). The guide line receivers 1910 may be formed as
holes or apertures and are sized to receive a guide line such as a
guide wire (not shown in FIGS. 19A-19D) to allow the implant member
1900 to ride on or otherwise be guided or advanced along the guide
line. The guide line may, for example, take the form of the guide
wire of FIGS. 5C, 5D and FIGS. 8C-8F. In various embodiments, the
guide line receivers 1910 allow implant member 1900 to ride on, or
otherwise be guided or advanced along a guide line that is received
or coupled to a tissue anchor that is embedded into tissue. The
guide line receivers 1910a, 1910c are located proximate a first end
1912a, a second end 1912b, respectively. The guide line receiver
1910b is between the first and second ends 1912a, 1912b. In
particular, each of the segments 1902 may have one of the guide
line receivers 1910. While illustrated as being approximately
midway between the first and second ends 1912a, 1912b, the guide
line receiver 1910b between the first and second ends 1912a, 1912b
may be offset to one side or the other of a center line
(perpendicular bisector 1924) of the implant member 1900, along a
longitudinal axis thereof. The implant member 1900 may include
additional guide line receivers (not shown). For instance, all or
some of one or more additional segments (not shown) may have guide
line receivers. Additionally, or alternatively, one segment 1902
may have more than one guide line receiver 1910. One or more of the
segments 1902 may include relief 1911 (only one called out in FIG.
19B) proximate the guide line receiver 1910. The relief 1911 may
accommodate a guide line such as a wire or suture.
[0195] As illustrated in FIGS. 19A and 19B, the segments 1902 of
the implant member 1900 may be moved with respect to one another,
into a first configuration, which in this illustrated embodiment is
representative of a delivery configuration or unanchored
configuration. In the delivery or unanchored configuration, the
implant member 1900 is sized and dimensioned to be deliverable via
a catheter. In the delivery configuration, the implant member 1900
may have an elongated, scallop or serpentine profile, as best
illustrated in FIG. 19B. A maximum longitudinal dimension in the
delivery or unanchored configuration is relatively long as compared
to the maximum longitudinal dimension in the implanted or anchored
configuration. Thus, a maximum lateral dimension of the implant
member 1900 (i.e., maximum dimension measured perpendicularly to a
longitudinal axis extending between the first and second ends
1912a, 1912b), is minimized. The maximum lateral dimension in the
delivery or unanchored configurations is relatively short or small
as compared to the maximum lateral dimension in a second
configuration, which in this illustrated embodiment is
representative of an implantable or deployed or anchored
configuration. As illustrated in FIG. 19B, the maximum lateral
dimension may, for example, be approximately equal to a height 1922
of the arch formed by the one of the arcuate segments 1902 (i.e.,
1902b in this illustrated embodiment), as measured by a
perpendicular bisector 1924 that extends from a chord line 1926
passing tangent to portions of an inner surface 1928 (called out
twice in FIG. 19B) of one or more of the arcuate segments 1902, to
where the perpendicular bisector 1924 intersects an outer surface
1930 of the arcuate segment 1902 when the plurality of arcuate
segments are positioned in the delivery or unanchored
configuration. Thus, the implant member 1900 may be accommodated by
a catheter. Catheters are typically long, but which have relatively
narrow diameters. Thus, catheters have relatively unlimited
longitudinal capacity as compared to lateral or radial
capacity.
[0196] As illustrated in FIGS. 19C and 19D, the segments 1902 of
the implant member 1900 may be moved with respect to one another
into the second configuration representative of an implantable or
deployed or anchored configuration. In the second configuration,
the implant member 1902 has an arcuate or annular shape or profile.
The arcuate or annular shape is sized and dimensioned to encompass
at least part of an orifice. For example, the arcuate or annular
shape may be sized and dimensioned to overlie part of an annulus of
a mitral valve of a heart. In the second configuration, the
dimensions of the implant member 1902 are too large to be
accommodated by a typical catheter. In particular, a lateral
dimension or height of the implant member is too large to be
received by a lumen of the catheter.
[0197] As described in detail below, forces or tension may be
applied to the implant member 1900 at the guide line receivers
1910, for instance via embedded tissue anchors and/or wires and/or
sutures. Such may tension the implant member 1900 into the second
configuration (FIGS. 19C and 19D), while the stops 1909 prevent the
segments 1902 of implant member 1900 from articulating past the
implanted configuration. Such results in the implant member 1900
having a rigid structure in the second configuration.
[0198] FIG. 20A-20D show an implant member 2000, according to one
illustrated embodiment. In particular, FIGS. 20A and 20B show the
implant member 2000 in a first configuration representative of a
delivery configuration or an unanchored configuration, while FIGS.
20C and 20D show the implant member 2000 in a second configuration
representative of a deployed configuration or an implantable
configuration or an anchored configuration. This implant member
2000 may be particularly suitable for use with the tissue anchors,
anchoring guiding frame and techniques of FIGS. 5C, 5D, and FIGS.
8C-8F, by way of non-limiting example.
[0199] The implant member 2000 may be used to reshape, reconfigure
and/or reinforce an orifice in bodily tissue. For example, the
implant member 2000 may be used to reshape, reconfigure and/or
reinforce a valve, for instance a natural valve or an artificial
valve. The valve may, for example take the form of a mitral,
tricuspid, pulmonary and/or aortic valve of the heart.
Alternatively, the valve may take the form of another valve in
another organ of the body.
[0200] The implant member 2000 has a plurality of arcuate segments
2002a-2002h (collectively 2002). While eight segments 2002 are
illustrated, the implant member 2000 may include fewer or greater
number of segments. The total number of segments 2002 may be based
on the size of the valve that the implant member 2000 will be used
with. The total number of segments 2002 may additionally or
alternatively be based on a largest lateral dimension that may be
accommodated by a given or desired catheter (i.e., diameter of
catheter lumen). For instance, employing a greater number of
segments 2002 means that the implant member 2000 may have a smaller
height in the first configuration, while still achieving a desired
lateral dimension or height of the overall implant member 2000 when
in the second configuration.
[0201] The segments 2002 are physically coupled to one another, and
in at least some configurations are articulated for movement with
respect to one another, for example pivotal movement. The implant
member 2000 includes a number of flexure joints 2004a-2004g
(collectively 2004) pivotally coupling neighboring ones of the
segments 2002. Each flexure joint 2004 may be defined by a recess
2006 (only one called out in FIG. 20C) defined in the implant
member 2000. Thus, in contrast to the implant member 1900 (FIGS.
19A-19D), the implant member 2000 may be a unitary structure formed
from a single piece of material. The recesses 2006 are illustrated
as being on an inner radius, diameter or surface 2019 of the
implant member 2000. Alternatively, recesses may be formed on an
outer radius, diameter or outer peripheral surface 2020 of the
implant member, diametrically opposed to the recesses 2006
illustrated in FIGS. 20A-20D.
[0202] The recesses 2006 may be defined or formed via machining
operations, for instance drilling, milling, laser cutting, water
jetting, etc. In particular the recesses 2006 may have an entrance
2008 (only one called out in FIG. 20C) at an inner peripheral
surface 2019 of the implant member 2000, and may have an enlarged
portion 2009 (only one called out in FIG. 20C) spaced inwardly of
the entrance 2008. The recesses 2006 may have rounded corners which
may alleviate stress and/or possible crack formation. Such may also
prevent snagging or tearing of bodily tissue.
[0203] The implant member 2000 may employ the resiliency of the
material from which the implant member 2000 is formed to limit the
bending or travel of the segments 2002. Alternatively, the implant
member 2000 may include stops proximate the flexure joints 2004.
The stops on neighboring ones of the segment 2002 would
cooperatively interact by engaging one another to prevent the
segments 2002 from being pivoted past a defined angle with respect
to one another. Accordingly, in various example embodiments, a
portion of implant member 2000 has a variable stiffness in at least
one dimensional plane. In a manner similar to other described
embodiments, the use of stops can allow implant member 2000 to have
a reduced bending stiffness when implant member 2000 is in its
first configuration and an increased bending stiffness when implant
member 2000 is in its second configuration. In this example
embodiment, a portion of implant member 2000 has a substantially
equal bending stiffness in each of a plurality of directions in at
least one dimensional plane when implant member 2000 is in its
first configuration while the portion of implant member 2000 has a
substantially unequal bending stiffness in each of the plurality of
directions in the at least one dimensional plane when implant
member 2000 is in its second configuration. In this example
embodiment, the stops provide the unequal bending stiffness in each
of the plurality of directions in the at least one dimensional
plane when implant member 2000 is in its second configuration.
[0204] The implant member 2000 includes a number of guide line
receivers 2010a-2000c (collectively 2010). The guide line receivers
2010 are formed as holes or apertures and are sized to receive a
guide line or wire (not shown in FIGS. 20A-20D) to allow the
implant member 2000 to ride on or otherwise be guided or advanced
along the guide line. The guide line receivers 2010 are located
proximate a first end 2012a, a second end 2012b and between 2012c
the first and second ends 2012a, 2012b. In particular, only some of
the segments 2002 may have one of the guide line receivers 2010.
While illustrated as being approximately midway between the first
and second ends 2012a, 2012b, the guide line receiver 2010b between
the first and second ends 2012a, 2012b may be offset to one side or
the other of a center line (perpendicular bisector 2024) of the
implant member 2000, along a longitudinal axis thereof. The implant
member 2000 may include additional guide line receivers (not
shown). For instance, all or some of one or more additional
segments (not shown) may have guide line receivers. Additionally,
or alternatively, one segment 2002 may have more than one guide
receiver 2010. Similar to previously described embodiments, each of
one or more of the segments 2002 may include a relief (not shown)
proximate the guide receiver 2010. Each of these reliefs may
accommodate a guide line such as a guide wire or suture.
[0205] As illustrated in FIGS. 20A and 20B, the segments 2002 of
the implant member 2000 may be moved with respect to one another,
into a first configuration representative of a delivery or
unanchored configuration. In the first configuration, the implant
member 2000 is sized and dimensioned to be deliverable via a
catheter. In the first configuration, the implant member 2000 may
have an elongated crenulated profile, as best illustrated in FIG.
20B. A maximum longitudinal dimension in the first configuration is
relatively long as compared to the maximum longitudinal dimension
in a second configuration that is representative of an implantable,
deployed or anchored configuration. Thus, a maximum lateral
dimension of the implant member 2000 (i.e., maximum dimension
measured perpendicularly to a longitudinal axis extending between
the first and second ends 2012a, 2012b), is reduced. The maximum
lateral dimension in the first configuration is relatively short or
small as compared to the maximum lateral dimension in the second
configuration. As illustrated in FIG. 20B, the maximum lateral
dimension may, for example, be approximately equal to a height 2022
of the arch formed by the implant member 2000, as measured by a
perpendicular bisector 2024 that extends from a chord line 2026
passing tangent to portions 2028 of an inner surface located at the
first and second ends 2012a, 2012b, to where the perpendicular
bisector 2024 intersects an outer surface 2020 of the implant
member 2000. Thus, the implant member 2000 may be accommodated by a
catheter, which catheters are typically long but which have
relatively narrow diameters.
[0206] As illustrated in FIGS. 20C and 20D, the segments 2002 of
the implant member 2000 may be moved with respect to one another
into a second configuration representative of an implantable,
deployed or anchored configuration. In the second configuration,
the implant member 2000 has an arcuate, annular or C-shape or
profile. The arcuate, annular or C-shape is sized and dimension to
encompass at least part of an orifice. In the second configuration,
the dimensions of the implant member 2000 are too large to be
accommodated by a typical catheter sheath. In particular, a lateral
dimension or height of the implant member is too large to be
received by a lumen of the catheter.
[0207] As described in detail below, forces or tension may be
applied to the implant member 2000 at the guide line receivers
2010, for instance via tissue anchors and/or guide lines, guide
wires and/or sutures. Such may tension the implant member 2000 into
the second configuration (FIGS. 20C and 20D).
[0208] FIG. 20E shows an implant cross member 2050, according to
one illustrated embodiment. The implant cross member 2050 may have
two or more guide line receivers 2052, to receive guide lines such
as guide wires (not shown in FIG. 20E). The guide line receivers
2052 may be proximate opposite ends of the implant cross member
2050. Thus, the implant cross member 2050 may ride or otherwise
advance along the guide lines or guide wires toward tissue anchors
embedded in tissue. The implant cross member 2050 can be anchored
across the ends of arms of an implant member such as implant member
1900 (FIGS. 19A-19D), or implant member 2000 (FIGS. 20A-20D) to
form a generally D-shape profile with the implant member. The
implant cross member 2050 may take the form of an elongated
generally rigid structure or an elongated cable or wire, which is
generally rigid once anchored. Such may result in a more rigid
structure than the structures having generally C-shaped profiles.
The implant cross member 2050 may optionally include couplers (not
shown) to couple to complimentary couplers on the implant member
1900, 2000.
[0209] In contrast to other valve reformation structures, at least
some of the implant members described herein such as implant
members 1900 (FIGS. 19A-19D), 2000 (FIGS. 20A-20D), do not need to
have a cable passing through all of the segments as the sole means
of coupling the various segments together. In contrast to other
valve reformation structures, implant members such as implant
members 1900 (FIGS. 19A-19D), 2000 (FIGS. 20A-20D) do not need to
be positioned on tissue surrounding a valve, and then secured to
the surrounding tissue and finally cinched together to alter the
shape of the valve. Rather, in various embodiments, implant members
such as implant members 1900, 2000 are secured to tissue anchors
(i.e., FIGS. 3, FIGS. 4A-4B, FIGS. 5A-5D, FIGS. 6A-6B, FIGS. 7A-7C
and FIGS. 8A-8D, by way of non-limiting example) that have been
previously embedded or previously anchored into the tissue
surrounding the orifice proximate at least three locations. It is
noted that in some example embodiments, each tissue anchor is
individually embedded into tissue, while in other example
embodiments, the tissue anchors are embedded into the tissue as a
group. In the previously described example embodiments, guide lines
that are received or coupled to the embedded tissue are received by
guide line receivers 1910, 2010 provided by respective ones of
implant members 1900, 2000 to provide a physical path for implant
member 1900, 2000 to travel to the embedded tissue anchors. As the
implant member 1900, 2000 travels towards the embedded tissue
anchors, each of the guidelines is configured to receive a tensile
force sufficient to apply force to bend or position implant member
1900, 2000 into its deployed or implantable configuration (i.e.,
the second configuration). In various example embodiments, at least
some of the guide lines impart force to the implant member 1900,
2000 as it moves along the physical path to the embedded tissue
anchors.
[0210] In various example embodiments, the implant member 1900,
2000 is appropriately sized and dimensioned so that the tensile
force applied to each of the guide lines is sufficient to cause a
portion of the tissue into which a respective tissue anchor is
embedded to move towards the implant member 1900, 2000 as the
implant member 1900, 2000 is positioned into its second
configuration. In various example embodiments, the segments 1902,
2002 of respective ones of the implant member 1900, 2000 in the
second configuration enclose at least partially, an area that is
smaller than an area of an annulus of an orifice (e.g., a mitral
valve) prior to a physical coupling between the implant member
1900, 2000 and the tissue. In various example embodiments, a
circumference defined by a circle passing through at least three
locations of the guide line receivers 1910, 2010 on a respective
one of the implant member 1900, 2000 in the second configuration is
smaller than a circumference of an annulus of the tissue orifice or
valve prior to a physical coupling between the implant member 1900,
2000 and the embedded tissue anchors. In various example
embodiments, a circumference defined by a circle passing through at
least three locations of the guide line receivers 1910, 2010 on a
respective one of the implant member 1900, 2000 in the second
configuration is smaller than a circumference defined by a circle
passing through at least three locations of the embedded tissue
anchors prior to a physical coupling between the implant member
1900, 2000 and the embedded tissue anchors.
[0211] It is noted that the force applied by the anchoring
maintains the implant member 1900, 2000 under tension in the
desired implantable configuration when the implant member 1900,
2000 is finally secured to the tissue. Advantageously, implant
member 1900, 2000 is positionable between a first configuration in
which respective ones of segments 1902, 2002 are articulable with
respect to one another such that the implant member 1900, 2000 is
manipulable to a size and dimension to be deliverable via a
catheter and a second configuration in which the segments 1902,
2002 form a structure sufficiently rigid to affect a shape of a
tissue valve or orifice in a desired manner. In this regard, each
of the implant member 1900, 2000 has a reduced bending stiffness in
at least one dimensional plane in the first configuration to allow
it to be deliverable via a catheter and an increased bending
stiffness in the at least one dimensional plane sufficient to form
a structure sufficiently rigid to affect the shape of a tissue
valve or orifice in a desired manner. In various example
embodiments, the guide lines and embedded tissue anchors apply
tension to the implant member 1900, 2000 in the second
configuration that is sufficient to restrain disengagement of a
respective one of a coupled segment 1902, 2002 with a stop
associated with the coupled segment. In various example
embodiments, the guide lines and embedded tissue anchors apply
tension to the implant member 1900, 2000 in the second
configuration that is sufficient to flex at least one of a
respective segment 1902, 2002 while the segment is engages with an
associated stop. The applied tension provided to the implanted
implant member 1900 in these example embodiments may reduce wear on
the components of the associated hinges 1904 as the implanted
implant member 1900 is subsequently repeatedly stressed by the
recipient's cardiac cycle which can be in the millions of cycles.
The applied tension provided to the implanted implant member 2000
in these example embodiments may reduce fatigue effects as the
implanted implant member 2000 is subsequently repeatedly stressed
by the recipient's cardiac cycle. While some of the described
embodiments may employ a cable between end segments of the
articulated structure as an implant cross member, adjacent pairs of
the segments are coupled together via respective hinges rather than
a cable.
[0212] The implant member 1900, 2000 may, for example, have a
length (e.g., measured from guide receiver 1910a to 1910b) of from
approximately 24 mm to approximately 38 mm, inclusive. Implant
members 1900, 2000 may be available in a variety of lengths, for
instance in 2 mm increments, to accommodate various valve sizes.
The implant members 1900, 2000 may have a thickness of approximate
2 mm, although other thickness may be employed. The width of the
segments of the implant members 1900, 2000 may, for example, be
approximately 2 mm, although other widths may be employed. The
implant members 1900, 2000 may, for example, have a height that is
between approximately 30% and approximately 50% of the longitudinal
length. The implant members 1900, 2000 may, for example, have a
height that is between approximately 60% and approximately 65% of
the longitudinal length, for example 63% of the longitudinal
length. Such ratio may provide sufficient force to approximate the
anterior-posterior dimension of a mitral valve.
[0213] In some embodiments, the implant member 1900, 2000 may, for
example, have an arcuate, annular or C-shape. The implant member
1900, 2000 may be sized and dimension to encompass over a third or
over half (i.e., substantially) of the orifice. For example, the
arcuate, annular or C-shape may be sized and dimensioned to overlie
part of an annulus of a mitral valve of a heart, surrounding
approximately half the mitral value. Such may advantageously allow
the anterior-posterior dimension of the mitral valve to be modified
(e.g., reduced). Implant members such as implant members 1900, 2000
may be formed from or comprise a variety of materials. The
materials may include a biocompatible material which does not react
in or with the tissue or bodily fluids. For example, the implant
members 1900, 2000 and/or implant cross member 2050 may be formed
of metals such as Nitinol, stainless steel, platinum, iridium,
titanium, or polymers such as polytetrafluoroethylene (PTFE) or
silicone. Also for example, the implant members 1900, 2000 and/or
implant cross member 2050 may be formed tissue (e.g., allograft,
autograft).
[0214] The implant members 1900, 2000 and/or implant cross member
2050 may have a textured exterior. Alternatively, implant members
1900, 2000 and/or implant cross member 2050 may take the form of a
tissue scaffold, for instance a scaffold constructed using 3-D
printing techniques. Such textured surface or scaffold may
encourage biological overgrowth. The implant members 1900, 2000
and/or implant cross member 2050 may carry one or more functional
coatings or layers. Such may either encourage or inhibit formation
of scarring, may deliver (e.g., elute) a therapeutic agent to the
organ or blood. Such may include gold, heparin, carbon
nanocomposite, silicon carbide, titanium-nitride-oxide,
phosphorylcholine, etc.
[0215] FIGS. 21A and 21B show a fastener 2100 that fastens to a
guide line such as a guide wire 2102, according to one illustrated
embodiment.
[0216] The fastener 2100 has a cavity 2104 which provides a passage
through the fastener 2100 for the guide line (e.g., Nitinol wire).
The cavity 2104 may include openings in two opposed surfaces of the
fastener 2100 to provide a passage for the guide line or guide wire
2102. The cavity 2104 may have a sloped wall 2106. The cavity 2104
may contain one or more cams or clutches 2108, for instance a
spring 2108a and ball 2108b. The ball 2108b is biased toward the
sloped wall 2106 by the spring 2108a. While illustrated as a coil
spring, other types of springs may be employed. The cam or clutch
2108 may include a seat 2108c which has a stem to retain the spring
2108a and an aperture or concavity to retain the ball 2108b. The
ball 2108b frictionally engages the guide line or guide wire 2102
against the sloped wall 2106 in response to movement of the
fastener 2100 along the guide line 2102 toward an embedded tissue
anchor (not shown in FIG. 21A or 21B). The fastener 2100 may be a
unidirectional or a one way fastener or clutch, allowing the
fastener 2100 to ride or move along the guide line or guide wire
2102 in one direction, but resisting movement in the opposite
direction. Such may be employed to secure the fastener 2100 against
the implant member (not shown in FIG. 21A or 21B) percutaneously,
to secure the implant member to the tissue anchors which are
embedded in the tissue. Other cams or clutches may be employed. For
instance, an arcuate section pivotally mounted and biased, for
example by a leaf spring, to engage the guide line or guide wire,
may be used. The fastener 2100 may be comprised of a biocompatible
material, for example a metal that does not react with bodily
tissues or fluids. The fastener 2100 may include a tubular housing,
which may be cylindrical. An end cap may be secured to the housing,
for example via spot welding. The fastener 2100 may, for example,
have a total volume of 8 cubic millimeters. The ball 2108b may, for
example, have a diameter of approximately 0.5 mm.
[0217] FIGS. 22A and 22B show a fastener 2200 that fastens a guide
line 2202 to a tissue anchor 2204, according to another illustrated
embodiment.
[0218] The fastener 2200 physically interacts with a fastening
portion 2206 of the tissue anchor 2204. In particular, the fastener
2200 has a sloped outer surface or swaging surface 2208 that is
received in a cavity 2210 of the fastening portion 2206 of the
tissue anchor 2204. Engagement of the inner wall forming the cavity
2210 plastically deforms the fastener 2200, increasing the
frictional force applied to the guide line 2202. Such can secure
the fastener to the tissue anchor 2204, secure the guide line 2202
to the fastener 2200. The fastener 2200 is a bidirectional
fastener, resisting movement of the guide line 2202 in either
direction once swaged. Such may be employed to secure the fastener
against the implant member in its second configuration (not shown
in FIG. 22A or 22B) to secure the implant member to the tissue
anchors embedded in the tissue. While illustrated with the fastener
2200 having a sloped surface 2208, in some embodiments, the inside
wall forming the cavity 2210 may be sloped to achieve a similar
result. The fastener 2200 may include a peripheral flange 2212 to
form a head. The size of the peripheral flange 2212 may be larger
than the openings of the implant member that receive the guide
lines 2202. The fastener 2200 may be comprised of a biocompatible
material, for example a metal that does not react with bodily
tissues or fluids.
[0219] Fasteners other than fasteners 2100, 2200 generally
described above may be employed in various example embodiments.
While illustrated as separate from the implant member, the
fasteners may be incorporated into the implant member. For example,
the fasteners 2100, 2200 may be secured to the implant member. For
instance, the fasteners 2100, 2200 may be secured in apertures or
recesses of the implant member, for example via press fit, swaging,
and/or adhesives, to become an integral part of the implant member.
Alternatively, the fasteners 2100, 2200 may be formed as a unitary,
single piece portion of the implant member. For instance, as
illustrated in FIG. 22C, a fastener may take the form of a
resilient member, such as a tab or pawl 2250, that extends into the
guide line receiver 2252 of an implant member 2254, and which
allows the guide line to easily advance in one direction but which
resists retreat of the guide line in the opposite direction. In
each of these examples, a passage through the fastener 2100, 2200,
2250 may serve as the guide line receiver.
[0220] FIGS. 24A-24H show an implant member 2400, according to one
illustrated embodiment. In particular, FIG. 24A shows the implant
member 2400 in a first configuration that is representative of one
of a delivery configuration, an unanchored configuration or an
untensioned configuration, while FIG. 24B show the implant member
2400 in a second configuration that is representative of one of an
implantable configuration, a deployed configuration, an anchored
configuration or a tensioned configuration.
[0221] The implant member 2400 is similar to previously described
implant member 1900 and may be used to reshape, reconfigure and/or
reinforce an orifice in bodily tissue. For example, the implant
member 2400 may be used to reshape, reconfigure and/or reinforce a
valve, for instance a natural valve or an artificial valve. The
valve may, for example take the form of a mitral, tricuspid,
pulmonary and/or aortic valve of the heart. Alternatively, the
valve may take the form of another valve in another organ of the
body.
[0222] The implant member 2400 has a plurality of arcuate segments
2402a-2402c (collectively 2402). While three segments 2402 are
illustrated, the implant member 2400 may include additional
segments. The total number of segments 2402 may be based on the
size of the valve with which the implant member 2400 will be used.
The total number of segments 2402 may additionally or alternatively
be based on a largest lateral dimension that may be accommodated by
a given or desired catheter (i.e., diameter of catheter lumen). For
instance, in manner similar to that described for implant member
1900, employing a greater number of segments 2402 means that each
segment may have a smaller height, while still achieving a desired
lateral dimension or height of the overall implant member 2400 when
in the second configuration.
[0223] The segments 2402 are physically coupled to one another, and
in at least some configurations are articulated for movement with
respect to one another, for example pivotal movement. The implant
member 2400 includes a number of hinges 2404a, 2404b (collectively
2404) pivotally coupling neighboring ones of the segments 2402.
Each hinge 2404 may include a hinge pin 2406a, 2406b (collectively
2406) received via throughholes 2408a, 2408b (collectively 2408) in
the segments 2402. Each hinge pin 2406 should be fixedly received
in the throughhole 2408 to ensure that the hinge pin 2406 does not
become dislodged after implantation. The hinge pin 2406 may be
swaged in the throughhole 2408, and may additionally or
alternatively be fixed using other mechanisms. The locations of the
hinge pins 2406 of the hinges 2404 may be offset from a
longitudinal centerline (i.e., the arc that passes longitudinally
through the geometric center between the longitudinal arcuate
edges) of the respective one of the arcuate segments 2402.
Alternatively, the hinge pins 2406 may lie along the longitudinal
centerline.
[0224] The segments 2402 include stops 2409a-2409d (collectively
2409) proximate the hinges 2404. The stops 2409 on neighboring ones
of the segments 2402 cooperatively interact by engaging one another
to prevent the segments 2402 from being pivoted past a defined
angle with respect to one another. The stops 2409 thus serve to
restrain the segments 2402 from further articulation in one
direction. While illustrated as simple complimentary engagement
surfaces, the stops may take other forms. For example, stops may
take the form of a detent or other lock structure. Stops 2409 may
lock the segments 2402 from moving along each of two opposing
directions when the implant member is in the second configuration.
Stops 2409 may also provide torsional stiffness to the hinges 1904.
Stops 2409 may also impart a greater bending stiffness to a portion
of the implant member 2400 in its second configuration than it has
in its first configuration.
[0225] As illustrated in FIGS. 24A and 24B, the segments 2402 of
the implant member 2400 may be moved with respect to one another
into a first configuration, which in this illustrated embodiment is
representative of a delivery configuration or unanchored
configuration or untensioned configuration. In the first
configuration, the implant member 2400 is sized and dimensioned to
be deliverable via a catheter. In the first configuration, the
implant member 2400 may have an elongated, scalloped, crenulated or
serpentine profile, as best illustrated in FIG. 24A. A maximum
longitudinal dimension in the first configuration is relatively
long as compared to the maximum longitudinal dimension in the
second configuration. As illustrated in FIGS. 24A and 24B, the
segments 2402 of the implant member 2400 may be moved with respect
to one another into the second configuration representative of an
implantable or deployed or anchored or tensioned configuration. In
the second configuration, the implant member 2400 has an arcuate
shape or profile. The arcuate shape is sized and dimensioned to
encompass at least part of an orifice. For example, the arcuate
shape may be sized and dimensioned to overlie part of an annulus of
a mitral valve of a heart. In the second configuration, the
dimensions of the implant member 2400 are too large to be
accommodated by a typical catheter sheath. In particular, a lateral
dimension or height of the implant member 2400 is too large to be
received by a lumen of the catheter sheath. Advantageously, the
articulated segments 2402 of implant member 2400 allow implant
member 2400 to be delivered percutaneously in a first configuration
while assuming a structure in a second configuration that is
sufficiently rigid to affect a shape of the tissue orifice in a
desired manner. In this example embodiment, implant member 2400 is
shown coupled with each helical tissue anchors 2418a, 2418b and
2418c (collectively tissue anchors 2418) which have been previously
embedded into tissue (not shown).
[0226] In a manner similar to other described embodiments, forces
or tension may be applied to the implant member 2400 at the guide
line receivers 2410 (one called out in FIG. 24A), for instance via
embedded helical tissue anchors and/or wires and/or sutures (not
shown in FIGS. 24A and 24B). Such may tension the implant member
2400 into the second configuration (FIG. 24B), while the stops 2409
prevent the segments 2402 of implant member 2400 from articulating
past the second configuration. Such results in implant member 2400
having a rigid structure in the second configuration.
[0227] In this illustrated embodiment, implant member 2400 has a
plurality of tissue anchor receivers 2412 (two called out in FIG.
24A), each of the tissue anchor receivers 2412 configured to
receive or mate with a respective one of the embedded helical
tissue anchors 2418 when implant member is positioned in the second
configuration. In this example embodiment, each of the guide line
receivers 2410 is co-axially aligned with a respective one of the
tissue anchor receivers, although other alignments may be employed
in other example embodiments. As implant member 2400 travels along
the guide lines extending from the embedded helical tissue anchors
2418, segments 2402 articulate about respective hinges 2404 to
position the implant member in the second configuration. Tensile
forces on the guide lines draw portions of the tissue into which
the helical tissue anchors 2418 are embedded towards implant member
2400 as implant member 2400 transitions into the second
configuration. Tensile forces on the guide lines move portions of
the tissue into which respective ones of the helical tissue anchors
2418 are embedded into locations where each of the embedded helical
tissue anchors 2418 is coupled with a respective one of the tissue
anchor receivers 2412 when the implant member 2400 is in the second
configuration. In this illustrated embodiment, various portions of
the tissue are moved to desired locations and are maintained in
these locations by the coupling of implant member 2400 to the
embedded helical tissue anchors 2418 via tissue anchor receivers
2412. In this illustrated embodiment, the coupled embedded helical
tissue anchors 2418 may cause portions of some of the segments 2402
to flex against associated stops 2408. In this illustrated
embodiment, the coupled embedded helical tissue anchors 2418
tension implant member 2400 in the second configuration. The
tension in the coupled implant member 2400 in the second
configuration may be sufficient to reduce a pivoting movement of at
least some of the segments 2402 about their associated hinges 2404
during the recipients subsequent cardiac cycle.
[0228] The locations of the embedded tissue anchors 2418 and the
locations of their respective tissue anchor receivers 2412 can be
configured to alter a shape of a tissue valve or orifice in a
desired manner. For example, FIG. 24C shows each of a first helical
tissue anchor 2418a, a second helical tissue anchor 2418b and a
third helical tissue anchor 2418c (collectively helical tissue
anchors 2418) embedded into a respective location about a periphery
of an orifice in a tissue 2430. In this example embodiment, a
location of the embedded third tissue anchor 2418c is laterally
offset by a first distance 2244 from a first axis 2440 (i.e., shown
in broken lines) that extends between a location of the embedded
first helical tissue anchor 2418a and a location of the embedded
second helical tissue anchor 2418b. In this example embodiment,
helical tissue anchors 2418 are embedded into tissue 2430 prior to
a coupling with implant member 2400. In this example embodiment,
the helical tissue anchors 2418 are embedded into tissue 2430 that
forms part of a heart. Specifically, the helical tissue anchors
2418 are embedded about a mitral annulus 2434 within a left atrium.
In this example embodiment, the location of each of the embedded
helical tissue anchors 2418 is proximate to mitral annulus 2434. In
this example embodiment, the location of each of the embedded
helical tissue anchors 2418 is proximate to a longitudinal axis of
the helical tissue anchor 2418. It is understood that the locations
of the embedded helical tissue anchors 2418 can be specified
relative to other datums in other example embodiments. In some
example embodiments, each of the helical tissue anchors 2418 is
transported sequentially through a catheter to their respective
implantation locations while in other example embodiments, two or
more of the helical tissue anchors 2418 are transported as a group
through a catheter to their respective implantation locations. In
some example embodiments, each helical tissue anchor 2418 is
implanted sequentially while in other example embodiments, two or
more of the helical tissue anchors 2418 are implanted at
substantially the same time or concurrently.
[0229] FIG. 24D shows implant member 2400 coupled with the helical
tissue anchors 2418 after they have been embedded into tissue 2430.
Implant member 2400 is reconfigurable between the first
configuration and the second configuration and is selected to
include at least a first tissue anchor receiver 2412a corresponding
to the first helical tissue anchor 2418a, a second tissue anchor
receiver 2412b corresponding to the second helical tissue anchor
2418b, and a third tissue anchor receiver 2412c corresponding to
the third helical tissue anchor 2418c. First tissue anchor receiver
2412a, second tissue anchor receiver 2412b and third tissue anchor
receiver 2412c are collectively referred to as tissue anchor
receivers 2412. As shown in FIG. 24D, implant member 2400 can be
selected such that a location of the third tissue anchor receiver
2412c on the implant member 2400 in the second configuration is
laterally offset by a second distance 2454 from a second axis 2450
(i.e., shown in broken lines) that extends between a location of
the first tissue anchor receiver 2412a on the implant member 2400
and a location of the second tissue anchor receiver 2412b on the
implant member 2400 such that the second distance 2454 is smaller
than the first distance 2444. In this example embodiment, the
location of each tissue anchor receiver 2412 is proximate to a
longitudinal axis of the tissue anchor receiver 2412. It is
understood that the locations of the tissue anchor receivers 2412
can be specified relative to other datums in other example
embodiments.
[0230] As shown in FIG. 24D, a coupling between the tissue anchor
receivers 2418 and the embedded helical tissue anchors 2418 will
affect a shape of the mitral annulus 2434 which can be used to
reposition mitral valve leaflets 2436 relative to one another in a
desired way. A coupling between the tissue anchor receivers 2412
and the embedded helical tissue anchors 2418 will cause a portion
of the tissue 2430 into which the third helical tissue anchor 2412c
is embedded to move relative to another portion of the tissue 2430
in a desired way. Other portions of the tissue 2430 can be moved in
a similar fashion based at least on the selection of an
appropriately sized and dimensioned implant member 2400.
[0231] The relationship between the locations of the embedded
helical tissue anchors 2418 and the locations of the tissue anchor
receivers 2412 employed to alter a shape of mitral annulus 2434 can
be illustrated in other ways. FIG. 24C shows that a circle 2460
(i.e., shown in broken line) can be dimensioned and sized to pass
through the locations of the embedded helical tissue anchors 2418.
In this example embodiment, a circumference of circle 2460 is
greater than a circumference or perimeter of mitral annulus 2434.
FIG. 24D shows that a circle 2470 (i.e., shown in broken line) can
be dimensioned and sized to pass through the locations of the
tissue anchor receivers 2412 when implant member 2440 is coupled
with the embedded tissue anchors 2418. In this example embodiment,
circle 2460 has a circumference that is greater than a
circumference of circle 2470.
[0232] FIGS. 24E and 24F respectively show a portion of a segment
2402 of implant member 2400 before and after a coupling with an
embedded helical tissue anchor 2418. Tissue into which helical
tissue anchor 2418 is embedded is not shown for clarity. In this
illustrated embodiment, a guide line 2416 extends from embedded
helical tissue anchor 2418 through the tissue anchor receiver 2412
and guide line receiver 2410 of segment 2402. Helical tissue anchor
2418 includes seat 2426 that is configured to mate or engage with
tissue anchor receiver 2412. In this illustrated embodiment, seat
2426 and tissue anchor receiver 2412 include mating tapered
surfaces. Seat 2426 and helical tissue anchor may be provided as a
unitary structure. Alternatively, seat 2426 may be secured to
helical tissue anchor 2418 by variety of methods including,
adhesives, crimping, and heat fitting, by way of non-limiting
example. In this illustrated embodiment, fastener 2420 is provided
via guide line 2416 to secure segment 2402 to embedded helical
tissue anchor 2418. Unlike other fasteners employed in other
described embodiments that secure an implant member to the tissue
by coupling with a guide line (e.g., fasteners 2100, 2200),
fastener 2420 couples directly with the embedded helical tissue
anchor 2418 itself as shown in FIG. 24F. In this illustrated
embodiment, fastener 2420 includes snap-ring features configured to
engage with groove 2421 in embedded helical tissue anchor 2418,
although other well known securement mechanisms can be employed in
other example embodiments. Spring 2424 is also provided via guide
line 2416 such that it is captured between fastener 2420 and
segment 2402. Spring 2420 can provide various functions which can
include by way of non-limiting example: preloading segment 2402
against the embedded helical tissue anchor 2418 to reduce
occurrences of the generation of potentially harmful wear
particulates, or compensating for component manufacturing or
assembly tolerances. Once implant member 2400 is secured to the
embedded helical tissue anchor 2418, guide line 2416 can be
decoupled from the embedded helical tissue anchor 2418. Decoupling
can include cutting guide line 2416 or drawing guide line 2416 from
an opening in embedded helical tissue anchor 2418 into which guide
line 2416 is looped. It is noted that this aspect is not limited to
helical tissue anchors such as helical tissue anchors 2418 and that
other forms of tissue anchors may be employed. For example, FIGS.
24G and 24H respectively show a portion of a segment 2402 of
implant member 2400 before and after a coupling with a grapple
tissue anchor 2500 as per another example embodiment. Specifically,
FIG. 24G shows an exploded isometric view of grapple tissue anchor
2500, the portion of segment 2402 and various other components
while FIG. 24H shows an assembled isometric view into which grapple
tissue anchor 2500 is secured to the portion of segment 2402 of
implant member 2400. In this example embodiment, grapple tissue
anchor 2500 is secured to implant member 2400 after grapple tissue
anchor 2500 has been implanted or embedded into tissue. Tissue into
which grapple tissue anchor 2500 is embedded is not shown for
clarity.
[0233] Grapple tissue anchor 2500 includes at least two elongate
members 2502a and 2502b (collectively elongated members 2502). Each
of the elongated members 2502 includes a first end 2504, a second
end 2506 and intermediate portion 2508 (only one called out in FIG.
24G) positioned along the elongate member 2502 between its first
end 2504 and its second end 2506. Each of the second ends 2506
includes a tip 2512 shaped to penetrate the tissue. Each of the
intermediate portions 2508 of the elongate members 2502 is
pivotably coupled together by a pivot 2510. In this example
embodiment, each of the elongated members 2502 includes an arcuate
shaped portion. Specifically, in this example embodiment, each of
the elongated members 2502 includes a portion between pivot member
2510 and the second end 2506 of the elongate member that extends
along an arcuate path. In this example embodiment, each of the
elongated members 2502 forms a prong.
[0234] Pivot member 2510 allows the elongated members 2502 to pivot
with respect to one another to position the tips 2512 spaced
relatively apart from one another at locations advantageous for
penetrating the tissue. Upon further deployment of grapple tissue
anchor 2500 into the tissue, the elongated members 2502 are pivoted
relative to each other to cause tips 2502 to travel along a path
through the tissue such that tips 2512 are positioned closer to one
another than during their initial deployment into the tissue. This
allows grapple tissue anchor 2500 to firmly anchor into the tissue.
To illustrate this, FIG. 24G shows the elongate members 2502
pivoted to the opposed tips 2512 spaced such that position grapple
tissue anchor 2500 would not be fully deployed into the tissue.
Whereas FIG. 24H shows the elongate members 2502 pivoted to
position the opposed tips 2512 such that grapple tissue anchor 2500
would be fully deployed into tissue. Those skilled in the art will
appreciate that other deployment configurations can be employed by
other grapple tissue anchors employed by various embodiments. For
example, each of the elongated members 2502 can be configured to
follow a different path through tissue during the deployment of the
grapple tissue anchor 2500 into tissue. In some example
embodiments, tips 2512 may, or may not overlap when grapple tissue
anchor 2500 is fully deployed into tissue.
[0235] In this example embodiment, grapple tissue anchor 2500 is
part of a tissue anchor system that includes at least one coupler
2530 that is physically coupled to at least one of the elongated
member 2502, the at least one coupler 2530 being additionally
configured to be received by implant member 2400 when the grapple
tissue anchor 2500 is secured to implant member 2400. In this
illustrated embodiment, a guide line 2514 extends from each
elongated member 2502. As best shown in FIG. 24G, a guide line
2514a extends from elongate member 2502a and a guide line 2514b
extends from elongate member 2502b. In this example embodiment,
each guide line 2514 is sized to be received through an opening
2516 (only one called out in FIG. 24G). In this example embodiment,
each of the guide lines 2514a and 2514b is looped through an
associated one of the openings 2516 (e.g., eyelet). This allows
each of the guide lines 2514 to be releasably coupled with an
associated one of the elongated members 2502, the coupling being
released by simply releasing an end of the guide line 2514 to allow
it to be extracted through an associated one of the openings
2516.
[0236] In this example embodiment, guide lines 2514 are also each
sized to be received through tissue anchor receiver 2412 and guide
line receiver 2410 provided in segment 2402. In this example
embodiment, guide lines 2514 are received through each of tissue
anchor receiver 2412 and guide line receiver 2410 after grapple
tissue anchor 2500 is embedded into tissue. In this particular
embodiment, the at least one coupler 2530 includes a two component
seat 2518 that is configured to mate or engage with tissue anchor
receiver 2412 in a similar manner to seat 2426 employed by the
embodiment illustrated in FIGS. 24E and 24F. Seat 2518 includes a
first seat component 2518a coupled to elongated member 2502a and a
second seat component 2518b coupled to elongate member 2502b. Each
component of seat 2518 and an associated one of the elongated
members 2502 can be provided in a unitary structure. Alternatively,
each component of seat 2518 may be secured to an associated one of
the elongated members 2502 by variety of methods including,
adhesives, crimping, and heat fitting, by way of non-limiting
example. When grapple tissue anchor 2500 is deployed into tissue,
seat 2518 is configured to mate or engage with tissue anchor
receiver 2412 in this illustrated example embodiment. In this
illustrated embodiment, the seat components 2518a and 2518b include
tapered surfaces configured to mate with a tapered surface provided
by tissue anchor receiver 2412 in a manner similar to that employed
by the embodiment illustrated in FIGS. 24E and 24F.
[0237] In this illustrated embodiment, fastener 2520 is provided
via guide lines 2514 to secure segment 2402 to embedded grapple
tissue anchor 2500. Unlike other fasteners employed in other
described embodiments that secure an implant member to the tissue
by coupling with a guide line (e.g., fasteners 2100, 2200),
fastener 2520 couples directly with the embedded grapple tissue
anchor 2500 itself as shown in FIG. 24H. In this illustrated
embodiment, fastener 2520 includes snap-ring features configured to
engage with a portion of groove 2521 provided in each of the
elongated members 2502, when grapple tissue anchor 2500 is embedded
into tissue. Spring 2524 is also provided via guide lines 2514 such
that it is captured between fastener 2520 and segment 2402. Spring
2520 can provide various functions which can include by way of
non-limiting example: preloading segment 2402 against the embedded
grapple tissue anchor 2500 to reduce occurrences of the generation
of potentially harmful wear particulates, or compensating for
component manufacturing or assembly tolerances. Once implant member
2400 is secured to the embedded grapple tissue anchor 2500, guide
lines 2514 can be decoupled from the embedded grapple tissue anchor
2500.
[0238] The present embodiments are not limited to securing grapple
tissue anchor 2500 to articulated implant members such as implant
member 2400. Other example embodiments may employ other members or
mechanisms to secure tissue anchors such as grapple tissue anchor
2500 to an implant member employed in an implant procedure. Without
limitation, various couplers 2530 can be employed to couple a
tissue anchor such as grapple tissue anchor 2500 to an implant
member. By way of non limiting example, coupler 2530 can include a
clamp configured to clamp a portion of the implant member. Coupler
2530 can include an extension sized to be received within an
opening provided in an implant member. Coupler 2530 can include an
expansion member configured to expand and grip one or more surfaces
of an implant member. Coupler 2530 can include a contraction member
configured to contract and grip one or more surfaces of an implant
member. Coupler 2530 can include detent or a snap-action
component.
[0239] FIGS. 23A-23T sequentially show an implant procedure
according to one illustrated embodiment. The implant procedure
includes placement of tissue anchors via an anchor guide frame at
selected locations in an annulus surrounding a mitral valve of a
left atrium of a heart, and the securement of an implant member to
the annulus via the embedded tissue anchors. Fluoroscopy, CT
scanning, trans-esophageal echo (TEE) and/or other imaging or
radiological techniques may be employed during all or part of the
medical procedure, for example for guiding various catheters and/or
locating the anchor guide frame for precisely placing or embedding
the tissue anchors. For instance, TEE techniques may be employed to
determine when to lock the implant member in position in the
implantable configuration with the fasteners. Ultrasound may be
employed before the medical procedure, or as part of the medical
procedure, to determine a size of the mitral valve. Such
information may be employed in selecting an appropriately sized
implant member or in adjusting a size of the implant member. In
some instances, the implant member may also be selected based on
the actual locations of the tissue anchors.
[0240] In particular, FIG. 23A shows a distal end 2300 of a cardiac
catheter 2302 advancing in a left atrium 2304 of a heart. The
cardiac catheter 2302 may, for example, enter the heart via an
inferior vena cava (not shown) or a superior vena cava (not shown),
then enter the left atrium via a hole formed in a septum (not
shown) of the heart. The cardiac catheter 2302 may be inserted
using an introducer and guide wire, as is commonly known. A
proximate end (not shown) of the cardiac catheter 2302 is outside
of the bodily or accessible from outside of the body.
[0241] An engagement or locating member 2306 of an anchor guide
frame 2308 is visible, extending out of the distal end 2300 of the
cardiac catheter 2302. The engagement or locating member 2306 may
have a number of arms 2306a (three illustrated, only one called out
in FIGS. 23A-23T) and a hub 2306b. The hub 2306b may couple the
arms 2306a. A mitral valve 2310 of the heart is also visible,
including an annulus 2312, which is natural tissue that surrounds
the mitral valve 2310. In use, the hub 2306b may be centered in the
mitral valve 2310 in contact with the cusps or leaflets of the
mitral valve 2310. The hub 2306b may take the form of an alignment
member, for instance the alignment fin 1305 previously described
with reference to FIG. 13.
[0242] FIG. 23B shows an anchoring catheter 2314 extending out of
the cardiac catheter 2302. The anchoring catheter 2314 carries the
anchor guide frame 2308. The anchoring catheter 2314 has a
steerable portion 2316, which may be selectively steered from a
location outside the body. The steerable portion 2316 may include
an articulated section. The steerable portion 2316 may be steered
mechanically, for example using wires (not shown in FIGS. 23A-23T)
that extend through the anchoring catheter 2314 and which are
attached to opposing portions of the articulated section.
Alternatively, the steerable portion 2316 may be steered
hydraulically, for example by controlling pressure in a number of
lumens that extend through the anchoring catheter and which
terminate in the articulated section. In addition to the engagement
or locating member 2306, the anchor guide frame 2308 includes a
number of anchor guides 2316 (three illustrated in FIGS. 23A-23T,
only one called out) which guide tissue anchors 2318 (FIGS.
23J-23T) to selected locations on the annulus 2312. The anchor
guides 2316 may each include a dual lumen outer tube 2320 (only one
called out in FIGS. 23A-23T). One lumen may carry a respective one
of the arms 2306a of the engagement or locating member 2306 for
movement through the lumen. The other lumen may carry an inner or
guide tube 2322, the tissue anchor 2318 and a guide line or guide
wire 2330 (only one called out in FIGS. 23M-23T) for movement
through the lumen. The inner or guide tube 2322 may be physically
coupled to advance the tissue anchor 2318 through the lumen. Such a
structure, and its use, were previously explained with reference to
FIGS. 8C-8F.
[0243] FIG. 23C shows the anchoring catheter 2314 being steered to
face the mitral valve 2310. FIG. 23D shows the anchoring catheter
2314 being advanced toward the mitral valve 2310.
[0244] FIG. 23E shows the engagement or locating member 2306 being
extended from the anchoring catheter 2314 toward the mitral valve
2310. FIG. 23F shows the anchor guide frame 2308 beginning to open
or expand, a slight bow in arms 2308a (only one called out in FIGS.
23F-23S) being visible in FIG. 23F. The anchor guide frame 2308 is
opened once the engagement or locating member 2306 or hub 2306b is
approximately in a desired position and orientation with respect to
the mitral valve 2310. FIGS. 23G and 23H show the anchor guide
frame 2308 opening or expanding further at successive intervals.
FIG. 23I shows the anchor guide frame 2308 fully open or expanded.
The anchor guide frame 2308 may move automatically into position
because of the correspondence of the shape of the anchor guide
frame 2308 with the anatomical structure of the valve. The anchor
guide frame 2308 may be constructed so that the two rear most arms
(as illustrated, one labeled 2306a and other one at the back of the
figure) slide into the mitral commissures. Even if the anchor guide
frame 2308 is deployed at the wrong angle, expanding the legs
caused the anchor guide frame 2308 to rotate as the legs get pushed
into the commissures. The mitral annulus is not perfectly round,
and "corners" of the mitral annulus can advantageously be used to
cause the anchor guide frame 2308 to automatically align with the
mitral valve.
[0245] FIG. 23J shows the inner or guide tubes 2322 with tissue
anchors 2318 beginning to protrude from the outer tubes 2320. FIGS.
23K and 23L show the inner or guide tubes 2322 with tissue anchors
2318 protruding further from the outer tubes 2320, at successive
intervals, embedding the tissue anchors 2318 into the annulus 2312
of the mitral valve 2310. FIG. 23M shows the inner or guide tubes
2322 being withdrawn back into the outer tubes 2320, leaving the
tissue anchors 2318 embedded in the tissue of the annulus 2312. The
guide line or guide wire 2330 is first visible in FIG. 23M. As
explained in reference to FIGS. 8C-8F, the guide line or guide wire
2330 may be pushed or held in place as the inner or guide tubes
2322 are withdrawn back into the outer tube 2320. FIG. 23N shows
the inner or guide tubes 2322 almost fully withdrawn in the outer
tube 2320, while FIG. 23O shows the inner or guide tubes 2322 fully
withdrawn in the outer tube 2320.
[0246] FIG. 23P shows the anchor guide frame 2308 closing or
collapsing. FIGS. 23Q and 23R shows the closed or collapsed anchor
guide frame 2308 and anchoring catheter 2314 being positioned and
oriented at successive intervals to be withdrawn into the cardiac
catheter 2302. FIG. 23S shows the anchoring catheter 2314 withdrawn
into the cardiac catheter 2302, leaving the tissue anchors 2318 and
guide lines or guide wires 2330 behind in the left atrium 2304 of
the heart. The anchoring catheter 2314 may then be removed,
clearing the cardiac catheter 2302 for the next catheter, used to
deliver an implant member. After the anchoring catheter 2314 is
withdrawn from the cardiac catheter 2302, the guide lines or guide
wires 2330 extend from the tissue anchors 2318 through the cardiac
catheter 2302 at least to the proximate end thereof. Such allows an
implant member to be coupled to the guide lines or guide wires
2330.
[0247] FIG. 23T shows a portion of an implant member 2332 being
advanced into the left atrium 2304 through the cardiac catheter
2302. The implant member 2332 may take the form of an annuloplasty
ring. As used herein and in the claims, a ring or annular structure
may be an open structure (e.g., C-shaped) or a closed structure
(O-shaped). The implant member 2332 has a number of guide line
receivers 2332a (only one illustrated in FIG. 23T) that couple the
implant member 2332 to a respective guide line or guide wire 2330.
In the illustrated embodiment, the guide line receiver 2332a takes
the form of a hole or aperture, sized to receive the guide line or
guide wire 2330. Such allows the implant member 2332 to ride or
otherwise advance along the guide lines or guide wires 2330 toward
the tissue anchors 2318 embedded in the tissue around an orifice
(e.g., mitral valve 2310). As previously explained in reference to
FIGS. 5C and 5D, the implant member 2332 may include a relief (not
illustrated in FIG. 23T) proximate the guide line receiver
2332a.
[0248] FIG. 23U shows the implant member 2332, guide lines or guide
wires 2318 and fasteners 2334 (only one called out in FIG. 23U),
according to one illustrated embodiment.
[0249] The implant member 2332 takes the form of an annuloplasty
ring. Suitable segmented structures for the implant member 2332
have been previously described, for example in reference to FIGS.
19A-19D, 20A-20D, and 24A-24H although other implant member
structures may be employed. The implant member 2332 is physically
attached directly or coupled indirectly to the annulus 2312 of the
mitral valve 2310. The implant member 2332 encompasses or surrounds
a portion of the mitral valve 2310, for example angularly
surrounding approximately half of the mitral valve 2310. In
particular, the implant member 2332 is positioned and oriented to
allow an anterior-posterior annular dimension of the mitral valve
2310 to be changed, for instance reduced. Such may cause the
leaflets of the mitral valve 2310 to better coapt.
[0250] The implant member 2332 may ride or otherwise advance along
the guide lines or guide wires 2318 to the locations on the annulus
2312 where the tissue anchors 2318 are embedded. A desired position
and orientation is achieved due to the ability to precisely locate
the tissue anchors 2318 using the anchor guide frame 2308. In
particular, the engagement or locating member 2306 or hub 2306b
and/or the anchor guides 2316 allows precise positioning and
orientation of the embedding of the tissue anchors 1218, and hence
the precise positioning and orientation of the implant member
2332.
[0251] In this example embodiment, fasteners 2334 are advanced
along each of the guide lines or guide wires 2330 to secure the
implant member 2332 to the annulus 2312. As previously described,
the fasteners 2334 may take a variety of forms. For example,
one-way clutch or cam mechanisms may allow the fasteners 2334 to
advance in one direction along the guide lines or guide wires 2330
toward the tissue anchors 2318, but prevent or resist retreat of
the fasteners 2334 along the guide lines or guide wires 2330 away
from the tissue anchors 2318. After the fasteners 2334 are in
place, excess portions of the guide lines or wires 2330 may be cut,
broken or otherwise severed, and the excess portions removed from
the body via the cardiac catheter 2302. Various embodiments of
suitable cutting or severing mechanisms have been described above.
Alternatively, a mechanism that facilitated a twisting or flexing
of the guide lines or guide wires 2330 may be employed. The guide
lines or guide wires 2330 are typically very fine, and may be
easily severed with appropriate twisting or rotation about a
longitudinal axis thereof. A small tail piece of guide line or
guide wire 2330 may be left exposed beyond the fastener 2334 to
allow later access, for example to replace the implant member 2332.
In other example embodiments, fasteners 2334 are employed to couple
directly with the embedded tissue anchors 2318 to secure implant
member 2332 to the annulus 2312. In some example embodiments
implant member 2332 and fasteners 2334 are combined into a unitary
structure.
[0252] The various embodiments described above can be combined to
provide further embodiments. All of any U.S. patents, U.S. patent
application publications, U.S. patent applications, foreign
patents, foreign patent applications and non-patent publications
referred to in this specification and/or listed in the Application
Data Sheet, including U.S. provisional patent application Ser. No.
61/278,232, filed Oct. 1, 2009, are incorporated herein by
reference, in their entirety. Aspects of the various embodiments
can be modified, if necessary, to employ systems, circuits and
concepts of the various patents, applications and publications to
provide yet further embodiments.
[0253] These and other changes can be made in light of the
above-detailed description. In general, in the following claims,
the terms used should not be construed to limit the invention to
the specific embodiments disclosed in the specification and the
claims, but should be construed to include all medical treatment
devices in accordance with the claims. Accordingly, the invention
is not limited by the disclosure, but instead its scope is to be
determined entirely by the following claims.
* * * * *